All FDA-approved EMA-approved PMDA-approved
Target Card Uniprot Example: P23975

exenatide 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
peptides and glycopeptides	1123	141758-74-9

Description:

Molecule

Description

Molfile Inchi Smiles Synonyms: exenatide byetta exenatide synthetic bydureon exendin-4 AC002993 AC2993A

A synthetic form of exendin-4, a 39-amino acid peptide isolated from the venom of the Gila monster lizard (Heloderma suspectum). Exenatide increases CYCLIC AMP levels in pancreatic acinar cells and acts as a GLUCAGON-LIKE PEPTIDE-1 RECEPTOR (GLP-1) agonist and incretin mimetic, enhancing insulin secretion in response to increased glucose levels; it also suppresses inappropriate glucagon secretion and slows gastric emptying. It is used an anti-diabetic and anti-obesity agent. Molecular weight: 4186.63 Formula: C184H282N50O60S CLOGP: LIPINSKI: None HAC: 110 HDO: 58 TPSA: 1749.75 ALOGS: ROTB: 134

Drug dosage:

Dose	Unit	Route
0.29	mg	P
15	mcg	P

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	25 mg/mL	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	0.00 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD

Approvals:

Date	Agency	Company	Orphan
April 28, 2005	FDA	ASTRAZENECA AB

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Pancreatitis	2019.55	16.85	736	22715	48319	63417252
Blood glucose increased	1915.12	16.85	821	22630	82935	63382636
Weight decreased	1138.37	16.85	884	22567	275914	63189657
Injection site nodule	958.52	16.85	233	23218	3602	63461969
Nausea	566.91	16.85	1072	22379	853399	62612172
Blood glucose decreased	562.31	16.85	231	23220	20721	63444850
Pancreatitis acute	382.47	16.85	191	23260	26975	63438596
Injection site haemorrhage	354.27	16.85	175	23276	24139	63441432
Injection site pruritus	352.34	16.85	215	23236	44901	63420670
Injection site mass	334.91	16.85	155	23296	18501	63447070
Glycosylated haemoglobin increased	316.61	16.85	132	23319	12266	63453305
Injection site extravasation	276.87	16.85	109	23342	8732	63456839
Injection site pain	237.02	16.85	265	23186	129535	63336036
Injection site urticaria	213	16.85	104	23347	13969	63451602
Vomiting	211.59	16.85	564	22887	559053	62906518
Incorrect dose administered by device	207.33	16.85	73	23378	4275	63461296
Device leakage	206.55	16.85	83	23368	7013	63458558
Hypoglycaemia	196.79	16.85	169	23282	59896	63405675
Injection site erythema	178.38	16.85	185	23266	82989	63382582
Decreased appetite	176.48	16.85	325	23126	250727	63214844
Wrong technique in device usage process	173.82	16.85	61	23390	3537	63462034
Injection site rash	168.49	16.85	98	23353	18711	63446860
Blood glucose abnormal	168.35	16.85	74	23377	7818	63457753
Injection site bruising	160.27	16.85	129	23322	41781	63423790
Pancreatic carcinoma	154.59	16.85	69	23382	7559	63458012
Lipase increased	125.80	16.85	65	23386	9835	63455736
Blood glucose fluctuation	124.50	16.85	51	23400	4525	63461046
Device delivery system issue	119.49	16.85	32	23419	737	63464834
Device malfunction	116.47	16.85	76	23375	17781	63447790
Injection site irritation	113.74	16.85	49	23402	4929	63460642
Incorrect dose administered	113.68	16.85	125	23326	59843	63405728
Early satiety	106.84	16.85	31	23420	965	63464606
Diabetic ketoacidosis	104.63	16.85	75	23376	20430	63445141
Pancreatitis chronic	104.45	16.85	38	23413	2446	63463125
Diabetes mellitus inadequate control	100.17	16.85	65	23386	15061	63450510
Product quality issue	99.67	16.85	92	23359	35773	63429798
Cholelithiasis	98.24	16.85	100	23351	43825	63421746
Intentional device misuse	90.46	16.85	26	23425	782	63464789
Pancreatic carcinoma metastatic	79.39	16.85	30	23421	2148	63463423
Infusion related reaction	77.63	16.85	3	23448	245518	63220053
Injury associated with device	76.97	16.85	34	23417	3632	63461939
Hyperglycaemia	73.72	16.85	84	23367	41783	63423788
Injection site swelling	73.07	16.85	89	23362	47483	63418088
Impaired gastric emptying	72.36	16.85	46	23405	10286	63455285
Eructation	70.87	16.85	42	23409	8291	63457280
Urticaria	70.26	16.85	175	23276	165627	63299944
Device issue	69.97	16.85	63	23388	23718	63441853
Underdose	67.83	16.85	66	23385	27390	63438181
Pain	67.67	16.85	106	23345	740522	62725049
Drug ineffective	66.51	16.85	184	23267	1044581	62420990
Joint swelling	63.46	16.85	21	23430	327645	63137926
Systemic lupus erythematosus	61.44	16.85	4	23447	208914	63256657
Drug intolerance	59.39	16.85	20	23431	308641	63156930
Amylase increased	59.30	16.85	34	23417	6311	63459260
Adenocarcinoma pancreas	58.74	16.85	20	23431	1058	63464513
Treatment failure	57.98	16.85	4	23447	199039	63266532
Toxicity to various agents	55.11	16.85	12	23439	247238	63218333
Nodule	54.68	16.85	52	23399	20974	63444597
Lactic acidosis	54.57	16.85	69	23382	38218	63427353
Device use issue	53.95	16.85	24	23427	2606	63462965
Needle issue	53.03	16.85	38	23413	10338	63455233
Arthralgia	52.46	16.85	81	23370	569629	62895942
Rheumatoid arthritis	51.40	16.85	15	23436	253804	63211767
Acute kidney injury	50.69	16.85	212	23239	263203	63202368
Blood triglycerides increased	48.89	16.85	39	23412	12449	63453122
Wound	48.37	16.85	3	23448	163260	63302311
Musculoskeletal stiffness	47.69	16.85	6	23445	184612	63280959
Arthropathy	47.31	16.85	14	23437	234778	63230793
Dehydration	46.24	16.85	155	23296	173199	63292372
Pyrexia	46.11	16.85	64	23387	470414	62995157
Abdominal pain	45.10	16.85	221	23230	293235	63172336
Pneumonia	44.89	16.85	62	23389	456705	63008866
Neutropenia	44.45	16.85	6	23445	174999	63290572
Increased appetite	44.09	16.85	33	23418	9597	63455974
Fatigue	43.57	16.85	175	23276	887853	62577718
Pancreatitis necrotising	42.92	16.85	18	23433	1694	63463877
Circumstance or information capable of leading to medication error	42.34	16.85	23	23428	3847	63461724
Injection site haematoma	41.92	16.85	28	23423	6804	63458767
Injection site abscess	41.85	16.85	16	23435	1182	63464389
Hunger	40.31	16.85	25	23426	5354	63460217
Injection site inflammation	39.73	16.85	22	23429	3821	63461750
Death	39.67	16.85	48	23403	374333	63091238
Infection	38.88	16.85	18	23433	229155	63236416
General physical health deterioration	35.45	16.85	15	23436	201387	63264184
Hepatic steatosis	35.03	16.85	48	23403	28721	63436850
Alopecia	34.99	16.85	44	23407	337492	63128079
White blood cell count decreased	34.78	16.85	5	23446	139099	63326472
Peripheral swelling	33.95	16.85	29	23422	265913	63199658
Intentional product use issue	33.40	16.85	4	23447	127888	63337683
Abdominal distension	33.10	16.85	88	23363	86527	63379044
Feeling jittery	32.69	16.85	32	23419	13371	63452200
Nasopharyngitis	32.12	16.85	28	23423	254229	63211342
Medication error	32.04	16.85	64	23387	52220	63413351
Pancreatitis relapsing	31.24	16.85	12	23439	898	63464673
Device defective	31.18	16.85	15	23436	1947	63463624
Product use in unapproved indication	30.47	16.85	14	23437	179066	63286505
Thrombocytopenia	30.45	16.85	9	23442	151148	63314423
Stomatitis	30.35	16.85	7	23444	138718	63326853
Injection site induration	30.25	16.85	26	23425	9200	63456371
Febrile neutropenia	30.22	16.85	4	23447	118445	63347126
Discomfort	30.20	16.85	12	23439	167362	63298209
Product dose omission issue	28.80	16.85	166	23285	234147	63231424
Sinusitis	28.58	16.85	25	23426	226628	63238943
Injection site cellulitis	27.52	16.85	12	23439	1242	63464329
Thyroid cancer	27.42	16.85	20	23431	5591	63459980
Swelling	26.39	16.85	38	23413	275340	63190231
Therapeutic product effect incomplete	26.02	16.85	7	23444	125049	63340522
Product quality control issue	25.92	16.85	5	23446	23	63465548
Disease progression	25.30	16.85	7	23444	122751	63342820
Body mass index abnormal	25.14	16.85	6	23445	85	63465486
Injection site indentation	24.80	16.85	7	23444	197	63465374
Product use issue	24.70	16.85	27	23424	220493	63245078
Hepatic enzyme increased	24.69	16.85	23	23428	202305	63263266
Renal failure	24.40	16.85	97	23354	117555	63348016
Cough	23.77	16.85	45	23406	292698	63172873
Vomiting projectile	23.41	16.85	11	23440	1355	63464216
Injection site warmth	22.63	16.85	28	23423	15167	63450404
Cholecystitis	22.36	16.85	28	23423	15349	63450222
Hypoglycaemic unconsciousness	22.30	16.85	9	23442	768	63464803
Bile duct stent insertion	21.87	16.85	5	23446	58	63465513
Pancreatitis haemorrhagic	21.84	16.85	8	23443	525	63465046
Helicobacter infection	21.70	16.85	4	23447	92781	63372790
Pancreatic duct stenosis	21.57	16.85	5	23446	62	63465509
Loss of personal independence in daily activities	21.10	16.85	5	23446	97285	63368286
Dyspnoea	20.83	16.85	151	23300	661162	62804409
Intestinal malrotation	20.51	16.85	7	23444	373	63465198
C-reactive protein increased	20.27	16.85	5	23446	94702	63370869
Medullary thyroid cancer	19.87	16.85	6	23445	215	63465356
Injection site infection	19.75	16.85	11	23440	1932	63463639
Angioedema	19.61	16.85	50	23401	47915	63417656
Confusional state	19.47	16.85	36	23415	236344	63229227
Pancreatic neoplasm	19.22	16.85	8	23443	738	63464833
Injection site reaction	18.95	16.85	56	23395	58468	63407103
Congenital intestinal malformation	18.84	16.85	4	23447	32	63465539
Product dispensing error	18.68	16.85	21	23430	10284	63455287
Platelet count decreased	18.35	16.85	10	23441	116112	63349459
Mobility decreased	18.34	16.85	11	23440	121148	63344423
Product prescribing error	18.33	16.85	34	23417	26255	63439316
Metastases to liver	18.30	16.85	32	23419	23607	63441964
Nail growth abnormal	18.04	16.85	7	23444	538	63465033
Condition aggravated	17.93	16.85	82	23369	402135	63063436
Gait disturbance	17.81	16.85	25	23426	183153	63282418
Glycosylated haemoglobin decreased	17.79	16.85	7	23444	559	63465012
Feeling abnormal	17.47	16.85	104	23347	148288	63317283
Hyponatraemia	17.16	16.85	10	23441	111890	63353681
Weight increased	17.09	16.85	159	23292	260633	63204938
Product administration error	16.93	16.85	30	23421	22367	63443204

FDA Adverse Event Reporting System (Male)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Pancreatitis	1783.45	18.38	678	16251	38213	34901789
Blood glucose increased	1127.36	18.38	577	16352	66141	34873861
Injection site nodule	957.95	18.38	210	16719	1473	34938529
Weight decreased	766.43	18.38	651	16278	175650	34764352
Pancreatitis acute	472.26	18.38	243	16686	27898	34912104
Device leakage	359.60	18.38	131	16798	6444	34933558
Injection site haemorrhage	353.18	18.38	144	16785	9624	34930378
Injection site mass	307.36	18.38	117	16812	6509	34933493
Pancreatic carcinoma	304.03	18.38	126	16803	8775	34931227
Nausea	287.49	18.38	554	16375	339354	34600648
Incorrect dose administered by device	266.67	18.38	77	16852	1781	34938221
Blood glucose decreased	259.10	18.38	127	16802	13110	34926892
Injection site pain	243.18	18.38	179	16750	38826	34901176
Glycosylated haemoglobin increased	234.37	18.38	113	16816	11247	34928755
Injection site extravasation	231.81	18.38	77	16852	2865	34937137
Wrong technique in device usage process	187.70	18.38	56	16873	1456	34938546
Blood glucose abnormal	159.51	18.38	71	16858	5881	34934121
Injection site pruritus	145.62	18.38	70	16859	6913	34933089
Device delivery system issue	144.27	18.38	36	16893	465	34939537
Cholelithiasis	138.35	18.38	100	16829	21048	34918954
Intentional device misuse	135.90	18.38	29	16900	175	34939827
Pancreatic carcinoma metastatic	129.43	18.38	50	16879	2890	34937112
Device malfunction	121.90	18.38	71	16858	10350	34929652
Lipase increased	120.43	18.38	68	16861	9348	34930654
Hypoglycaemia	102.13	18.38	129	16800	54511	34885491
Product quality issue	98.93	18.38	75	16854	16960	34923042
Needle issue	93.96	18.38	50	16879	6115	34933887
Injection site erythema	92.33	18.38	70	16859	15829	34924173
Underdose	85.20	18.38	63	16866	13717	34926285
Adenocarcinoma pancreas	84.95	18.38	30	16899	1344	34938658
Diabetes mellitus inadequate control	84.25	18.38	62	16867	13402	34926600
Drug delivery system issue	83.18	18.38	14	16915	14	34939988
Vomiting	79.84	18.38	282	16647	247339	34692663
Injection site urticaria	76.38	18.38	31	16898	2041	34937961
Device issue	72.65	18.38	50	16879	9727	34930275
Decreased appetite	72.23	18.38	210	16719	166182	34773820
Toxicity to various agents	71.87	18.38	7	16922	200355	34739647
Injection site bruising	70.81	18.38	47	16882	8616	34931386
Blood glucose fluctuation	70.80	18.38	36	16893	4008	34935994
Drug dose omission by device	70.72	18.38	30	16899	2209	34937793
Incorrect dose administered	69.94	18.38	92	16837	40423	34899579
Pancreatitis chronic	64.13	18.38	28	16901	2212	34937790
Device use issue	63.24	18.38	20	16909	634	34939368
Pancreatitis necrotising	55.53	18.38	27	16902	2731	34937271
Death	53.34	18.38	69	16860	397980	34542022
Injection site rash	53.11	18.38	30	16899	4123	34935879
Pancreaticoduodenectomy	52.64	18.38	11	16918	59	34939943
Neutropenia	52.38	18.38	7	16922	156771	34783231
Pyrexia	51.92	18.38	51	16878	332962	34607040
Metastases to liver	49.86	18.38	46	16883	13617	34926385
Diabetic ketoacidosis	49.57	18.38	52	16877	17980	34922022
Cholecystectomy	48.65	18.38	25	16904	2845	34937157
Injection site swelling	48.38	18.38	42	16887	11485	34928517
Injection site abscess	46.69	18.38	17	16912	832	34939170
Injection site irritation	46.62	18.38	19	16910	1264	34938738
Thrombocytopenia	45.56	18.38	10	16919	156237	34783765
Pneumonia	45.38	18.38	66	16863	362561	34577441
Injection site reaction	43.95	18.38	42	16887	12991	34927011
Product use in unapproved indication	42.37	18.38	4	16925	117495	34822507
Amylase increased	40.78	18.38	29	16900	5939	34934063
Nodule	39.52	18.38	30	16899	6789	34933213
Anaemia	38.35	18.38	34	16895	233301	34706701
Disease progression	38.12	18.38	4	16925	108073	34831929
Drug abuse	36.73	18.38	3	16926	99093	34840909
Blood triglycerides increased	35.68	18.38	39	16890	14120	34925882
Hepatic steatosis	35.29	18.38	44	16885	18318	34921684
Renal failure	34.69	18.38	140	16789	130417	34809585
Platelet count decreased	34.21	18.38	8	16921	119709	34820293
Impaired gastric emptying	33.82	18.38	21	16908	3432	34936570
Injection site induration	32.15	18.38	19	16910	2841	34937161
Injury associated with device	32.02	18.38	14	16915	1109	34938893
Malignant neoplasm progression	31.72	18.38	3	16926	88043	34851959
Circumstance or information capable of leading to medication error	31.61	18.38	16	16913	1763	34938239
Hyperglycaemia	31.30	18.38	63	16866	39417	34900585
General physical health deterioration	30.46	18.38	12	16917	128257	34811745
White blood cell count decreased	30.15	18.38	5	16924	95440	34844562
Pancytopenia	30.03	18.38	5	16924	95152	34844850
Pancreatic neuroendocrine tumour	29.45	18.38	9	16920	254	34939748
Injection site injury	29.42	18.38	9	16920	255	34939747
Abdominal pain upper	28.80	18.38	88	16841	71402	34868600
Pancreatic neoplasm	28.12	18.38	12	16917	896	34939106
Bile duct stent insertion	28.08	18.38	7	16922	90	34939912
Fatigue	27.61	18.38	90	16839	370563	34569439
Pancreatitis haemorrhagic	27.13	18.38	9	16920	333	34939669
Pancreatic stent placement	27.05	18.38	5	16924	12	34939990
COVID-19	27.01	18.38	3	16926	77547	34862455
Device defective	26.66	18.38	11	16918	755	34939247
Drug interaction	26.39	18.38	43	16886	225903	34714099
Injection site cellulitis	25.99	18.38	10	16919	571	34939431
Biliary dyskinesia	25.72	18.38	6	16923	57	34939945
Therapeutic product effect decreased	24.68	18.38	53	16876	34690	34905312
Abdominal pain	24.48	18.38	149	16780	163469	34776533
Early satiety	24.16	18.38	10	16919	692	34939310
Eructation	23.49	18.38	19	16910	4712	34935290
Pancreatic cyst	23.04	18.38	10	16919	778	34939224
Condition aggravated	22.98	18.38	36	16893	192160	34747842
Pancreatic pseudocyst	22.35	18.38	10	16919	837	34939165
Drug delivery system malfunction	22.22	18.38	8	16921	379	34939623
Hyperlipidaemia	22.02	18.38	31	16898	14498	34925504
Feeling jittery	21.86	18.38	17	16912	3986	34936016
Injection site discomfort	21.59	18.38	12	16917	1598	34938404
Distributive shock	21.47	18.38	11	16918	1243	34938759
Pancreatic enzymes increased	21.47	18.38	9	16920	643	34939359
Hepatic cancer	21.21	18.38	23	16906	8252	34931750
Insulin-requiring type 2 diabetes mellitus	20.52	18.38	6	16923	145	34939857
Leukopenia	20.51	18.38	3	16926	62853	34877149
Injection site haematoma	20.44	18.38	12	16917	1773	34938229
Diverticulum	20.30	18.38	21	16908	7138	34932864
Dehydration	19.83	18.38	119	16810	129850	34810152
Injection site scar	19.81	18.38	7	16922	314	34939688
Hypoglycaemic unconsciousness	19.72	18.38	9	16920	789	34939213
Pancreatic duct dilatation	19.53	18.38	5	16924	72	34939930
Interstitial lung disease	19.37	18.38	4	16925	65278	34874724
Haemoglobin decreased	19.32	18.38	18	16911	120754	34819248
Diabetic neuropathy	19.05	18.38	16	16913	4181	34935821
Cholecystitis chronic	18.78	18.38	9	16920	881	34939121
Hunger	18.62	18.38	11	16918	1643	34938359
Glycosylated haemoglobin decreased	18.53	18.38	7	16922	380	34939622
Injection site indentation	18.49	18.38	4	16925	26	34939976

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Blood glucose increased	2091.43	17.60	895	22435	114080	79606978
Pancreatitis	1583.55	17.60	634	22696	67941	79653117
Injection site nodule	1085.95	17.60	246	23084	3534	79717524
Weight decreased	999.46	17.60	825	22505	354373	79366685
Nausea	630.75	17.60	1050	22280	956146	78764912
Blood glucose decreased	513.47	17.60	216	23114	26018	79695040
Injection site haemorrhage	442.51	17.60	198	23132	27672	79693386
Device leakage	378.51	17.60	136	23194	10720	79710338
Incorrect dose administered by device	367.17	17.60	110	23220	4879	79716179
Pancreatitis acute	361.13	17.60	208	23122	49396	79671662
Glycosylated haemoglobin increased	345.05	17.60	149	23181	19111	79701947
Injection site pruritus	333.88	17.60	187	23143	42096	79678962
Injection site mass	315.87	17.60	142	23188	20042	79701016
Injection site pain	271.45	17.60	256	23074	129582	79591476
Wrong technique in device usage process	254.52	17.60	79	23251	3949	79717109
Device delivery system issue	250.52	17.60	55	23275	676	79720382
Hypoglycaemia	227.10	17.60	208	23122	101386	79619672
Vomiting	221.59	17.60	553	22777	665275	79055783
Injection site extravasation	217.48	17.60	88	23242	9581	79711477
Decreased appetite	206.02	17.60	363	22967	342055	79379003
Injection site urticaria	199.88	17.60	90	23240	12736	79708322
Pancreatic carcinoma	191.86	17.60	89	23241	13488	79707570
Blood glucose abnormal	186.76	17.60	81	23249	10485	79710573
Injection site erythema	164.81	17.60	155	23175	78042	79643016
Injection site bruising	148.18	17.60	111	23219	40891	79680167
Product quality issue	148.06	17.60	103	23227	33837	79687221
Device malfunction	145.54	17.60	86	23244	21362	79699696
Lipase increased	144.12	17.60	78	23252	16388	79704670
Incorrect dose administered	142.85	17.60	142	23188	76488	79644570
Blood glucose fluctuation	140.65	17.60	58	23272	6624	79714434
Injection site rash	121.84	17.60	72	23258	17882	79703176
Injection site irritation	111.79	17.60	42	23288	3748	79717310
Diabetic ketoacidosis	109.31	17.60	86	23244	34036	79687022
Needle issue	103.61	17.60	58	23272	13010	79708048
Diabetes mellitus inadequate control	97.39	17.60	70	23260	24194	79696864
Device use issue	86.31	17.60	32	23298	2752	79718306
Underdose	86.16	17.60	74	23256	33077	79687981
Toxicity to various agents	79.12	17.60	14	23316	421526	79299532
Drug delivery system issue	78.63	17.60	15	23315	85	79720973
Early satiety	77.53	17.60	25	23305	1414	79719644
Intentional device misuse	74.07	17.60	21	23309	764	79720294
Injection site swelling	71.04	17.60	78	23252	47054	79674004
Cholelithiasis	70.60	17.60	82	23248	52582	79668476
Eructation	69.47	17.60	42	23288	10867	79710191
Amylase increased	65.87	17.60	41	23289	11168	79709890
Acute kidney injury	64.97	17.60	312	23018	519092	79201966
Pyrexia	64.80	17.60	62	23268	678647	79042411
Drug dose omission by device	64.32	17.60	33	23297	6217	79714841
Device issue	63.40	17.60	57	23273	27051	79694007
Urticaria	63.38	17.60	156	23174	185045	79536013
Injury associated with device	59.09	17.60	26	23304	3480	79717578
Pneumonia	57.72	17.60	65	23265	660181	79060877
Neutropenia	55.17	17.60	9	23321	287701	79433357
Infusion related reaction	55.11	17.60	3	23327	230234	79490824
Hyperglycaemia	53.42	17.60	83	23247	70252	79650806
Febrile neutropenia	52.36	17.60	4	23326	230995	79490063
Lactic acidosis	52.01	17.60	82	23248	70277	79650781
Impaired gastric emptying	51.27	17.60	34	23296	10319	79710739
Pancreatic carcinoma metastatic	48.08	17.60	23	23307	3730	79717328
Thrombocytopenia	45.21	17.60	11	23319	265248	79455810
Feeling jittery	44.67	17.60	34	23296	12807	79708251
Abdominal distension	44.35	17.60	104	23226	119546	79601512
Product use in unapproved indication	43.42	17.60	10	23320	250349	79470709
Injection site induration	43.27	17.60	30	23300	9789	79711269
Dehydration	43.23	17.60	165	23165	248022	79473036
Device defective	41.54	17.60	17	23313	1903	79719155
Pancreatitis necrotising	41.27	17.60	21	23309	3887	79717171
Circumstance or information capable of leading to medication error	41.07	17.60	21	23309	3927	79717131
Drug intolerance	39.44	17.60	14	23316	264105	79456953
Treatment failure	38.49	17.60	3	23327	170483	79550575
White blood cell count decreased	38.14	17.60	5	23325	188283	79532775
Injection site inflammation	38.06	17.60	20	23310	3956	79717102
General physical health deterioration	37.17	17.60	17	23313	275221	79445837
Injection site abscess	37.12	17.60	15	23315	1625	79719433
Injection site indentation	36.75	17.60	9	23321	183	79720875
Joint swelling	35.73	17.60	20	23310	288626	79432432
Platelet count decreased	35.33	17.60	7	23323	194657	79526401
Disease progression	34.81	17.60	6	23324	184356	79536702
Product dose omission issue	34.75	17.60	154	23176	247383	79473675
Adenocarcinoma pancreas	34.01	17.60	15	23315	2018	79719040
Increased appetite	33.71	17.60	28	23302	11950	79709108
Injection site cellulitis	33.40	17.60	14	23316	1664	79719394
Death	33.07	17.60	73	23257	566441	79154617
Anaemia	32.48	17.60	50	23280	444965	79276093
Device failure	32.06	17.60	21	23309	6240	79714818
Blood triglycerides increased	32.00	17.60	35	23295	21005	79700053
Pain	31.79	17.60	103	23227	703699	79017359
Rheumatoid arthritis	31.20	17.60	11	23319	208459	79512599
Abdominal pain	30.69	17.60	207	23123	389362	79331696
Feeling abnormal	29.49	17.60	108	23222	159091	79561967
Malignant neoplasm progression	29.06	17.60	3	23327	135987	79585071
Musculoskeletal stiffness	28.39	17.60	8	23322	175000	79546058
Injection site injury	28.32	17.60	10	23320	747	79720311
Ketoacidosis	27.77	17.60	21	23309	7833	79713225
Hyponatraemia	27.28	17.60	9	23321	177839	79543219
Medication error	25.79	17.60	60	23270	68582	79652476
Injection site reaction	25.26	17.60	52	23278	54733	79666325
Glycosylated haemoglobin decreased	25.23	17.60	9	23321	693	79720365
Peripheral swelling	25.22	17.60	25	23305	269592	79451466
Renal failure	25.21	17.60	121	23209	200847	79520211
Stomatitis	25.16	17.60	6	23324	146751	79574307
Cough	25.07	17.60	43	23287	366746	79354312
Hunger	24.90	17.60	17	23313	5411	79715647
Injection site haematoma	24.26	17.60	16	23314	4811	79716247
Wound	23.73	17.60	3	23327	116176	79604882
Injection site infection	23.69	17.60	12	23318	2200	79718858
Injection site discomfort	23.27	17.60	16	23314	5150	79715908
Intentional product use issue	22.80	17.60	8	23322	152104	79568954
Lower respiratory tract infection	22.71	17.60	5	23325	129215	79591843
Oxygen saturation decreased	22.67	17.60	5	23325	129042	79592016
Coronary artery occlusion	22.47	17.60	25	23305	15290	79705768
Drug ineffective	22.20	17.60	206	23124	1080707	78640351
Therapeutic product effect incomplete	22.02	17.60	7	23323	141638	79579420
Infection	21.93	17.60	23	23307	241689	79479369
Pancreatitis chronic	21.86	17.60	14	23316	4005	79717053
Therapeutic response unexpected	21.76	17.60	28	23302	19918	79701140
Arthralgia	21.62	17.60	90	23240	571713	79149345
Nodule	21.59	17.60	30	23300	22964	79698094
Fatigue	21.39	17.60	172	23158	929555	78791503
Hyperhidrosis	21.05	17.60	94	23236	151398	79569660
Arthropathy	20.87	17.60	13	23317	177098	79543960
COVID-19	20.87	17.60	10	23320	157664	79563394
C-reactive protein increased	20.74	17.60	6	23324	129021	79592037
Confusional state	20.19	17.60	39	23291	317958	79403100
Distributive shock	18.81	17.60	11	23319	2676	79718382
Hepatic steatosis	18.80	17.60	37	23293	37701	79683357
Dyspepsia	18.68	17.60	72	23258	108615	79612443
Interstitial lung disease	18.53	17.60	5	23325	112595	79608463
Cardiac arrest	18.46	17.60	14	23316	172082	79548976
Seizure	18.24	17.60	17	23313	188817	79532241
Therapeutic product effect decreased	17.96	17.60	95	23235	163768	79557290
Drug delivery system malfunction	17.76	17.60	7	23323	710	79720348
Leukopenia	17.68	17.60	6	23324	116507	79604551

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	A10BJ01	ALIMENTARY TRACT AND METABOLISM DRUGS USED IN DIABETES BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS Glucagon-like peptide-1 (GLP-1) analogues
FDA CS	M0160181	Glucagon-Like Peptide 1
FDA MoA	N0000020058	Glucagon-like Peptide-1 (GLP-1) Agonists
MeSH PA	D019440	Anti-Obesity Agents
MeSH PA	D006728	Hormones
MeSH PA	D007004	Hypoglycemic Agents
MeSH PA	D054795	Incretins
FDA EPC	N0000178480	GLP-1 Receptor Agonist
CHEBI has role	CHEBI:35526	antidiabetic
CHEBI has role	CHEBI:64088	incretin mimetics
CHEBI has role	CHEBI:71196	GLP-1 receptor agonist

Drug Use | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
Type 2 Diabetes Mellitus Treatment Adjunct	indication
Alcoholism	contraindication	7200002
Acute vomiting	contraindication	23971007
Dehydration	contraindication	34095006
Hypertensive disorder	contraindication	38341003	DOID:10763
Acute nephropathy	contraindication	58574008
Transplant of kidney	contraindication	70536003
Pancreatitis	contraindication	75694006	DOID:4989
Chronic renal failure syndrome	contraindication	90688005
Impaired renal function disorder	contraindication	197663003
Gastroparesis	contraindication	235675006
Hypoglycemic disorder	contraindication	237630007
Calculus in biliary tract	contraindication	266474003
Severe diarrhea	contraindication	409587002

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	3.15	acidic
pKa2	3.62	acidic
pKa3	3.86	acidic
pKa4	4.07	acidic
pKa5	4.31	acidic
pKa6	4.6	acidic
pKa7	12.09	acidic
pKa8	12.31	acidic
pKa9	12.61	acidic
pKa10	12.68	acidic
pKa11	12.87	acidic
pKa12	12.92	acidic
pKa13	12.99	acidic
pKa14	13.18	acidic
pKa15	13.2	acidic
pKa16	13.29	acidic
pKa17	13.3	acidic
pKa18	13.4	acidic
pKa19	13.5	acidic
pKa20	13.51	acidic
pKa21	13.52	acidic
pKa22	13.64	acidic
pKa23	13.68	acidic
pKa24	13.77	acidic
pKa25	13.82	acidic
pKa26	13.86	acidic
pKa27	11.25	Basic
pKa28	10.81	Basic
pKa29	10.31	Basic
pKa30	7.86	Basic
pKa31	5.98	Basic

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9238076	April 15, 2024	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH BASAL INSULIN OR BASAL INSULIN PLUS METFORMIN
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9238076	April 15, 2024	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9238076	April 15, 2024	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN, A SULFONYLUREA, A THIAZOLIDINEDIONE, OR COMBINATION OF ANY TWO OF THESE THERAPIES
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9238076	April 15, 2024	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH INSULIN ALONE OR INSULIN PLUS ONE OTHER ORAL ANTIDIABETIC MEDICATION
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9238076	April 15, 2024	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN AND/OR SULFONYLUREA
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9238076	April 15, 2024	IMPROVING GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE TO PROVIDE A RELEASE PROFILE HAVING A RATIO OF C-MAX TO C-AVG OF ABOUT 3 OR LESS
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9238076	April 15, 2024	IMPROVING GLYCEMIC CONTROL IN PATIENTS 10 YEARS OF AGE AND OLDER WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING A SUSTAINED-RELEASE EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9238076	April 15, 2024	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH BASAL INSULIN OR BASAL INSULIN PLUS METFORMIN
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9238076	April 15, 2024	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9238076	April 15, 2024	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN, A SULFONYLUREA, A THIAZOLIDINEDIONE, OR COMBINATION OF ANY TWO OF THESE THERAPIES
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9238076	April 15, 2024	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH INSULIN ALONE OR INSULIN PLUS ONE OTHER ORAL ANTIDIABETIC MEDICATION
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9238076	April 15, 2024	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN AND/OR SULFONYLUREA
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9238076	April 15, 2024	IMPROVING GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE TO PROVIDE A RELEASE PROFILE HAVING A RATIO OF C-MAX TO C-AVG OF ABOUT 3 OR LESS
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9238076	April 15, 2024	IMPROVING GLYCEMIC CONTROL IN PATIENTS 10 YEARS OF AGE AND OLDER WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING A SUSTAINED-RELEASE EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9238076	April 15, 2024	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH BASAL INSULIN OR BASAL INSULIN PLUS METFORMIN
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9238076	April 15, 2024	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9238076	April 15, 2024	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AS ADD-ON TO METFORMIN
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9238076	April 15, 2024	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN, A SULFONYLUREA, A THIAZOLIDINEDIONE, OR COMBINATION OF ANY TWO OF THESE THERAPIES
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9238076	April 15, 2024	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH INSULIN ALONE OR INSULIN PLUS ONE OTHER ORAL ANTIDIABETIC MEDICATION
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9238076	April 15, 2024	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN AND/OR SULFONYLUREA
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9238076	April 15, 2024	IMPROVING GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE TO PROVIDE A RELEASE PROFILE HAVING A RATIO OF C-MAX TO C-AVG OF ABOUT 3 OR LESS
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9238076	April 15, 2024	IMPROVING GLYCEMIC CONTROL IN PATIENTS 10 YEARS OF AGE AND OLDER WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING A SUSTAINED-RELEASE EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	7612176	April 13, 2025	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH BASAL INSULIN OR BASAL INSULIN PLUS METFORMIN
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	7612176	April 13, 2025	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	7612176	April 13, 2025	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN, A SULFONYLUREA, A THIAZOLIDINEDIONE, OR COMBINATION OF ANY TWO OF THESE THERAPIES
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	7612176	April 13, 2025	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH INSULIN ALONE OR INSULIN PLUS ONE OTHER ORAL ANTIDIABETIC MEDICATION
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	7612176	April 13, 2025	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN AND/OR SULFONYLUREA
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	7612176	April 13, 2025	IMPROVING GLYCEMIC CONTROL IN PATIENTS 10 YEARS OF AGE AND OLDER WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING A SUSTAINED-RELEASE EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8431685	April 13, 2025	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH BASAL INSULIN OR BASAL INSULIN PLUS METFORMIN
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8431685	April 13, 2025	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8431685	April 13, 2025	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN, A SULFONYLUREA, A THIAZOLIDINEDIONE, OR COMBINATION OF ANY TWO OF THESE THERAPIES
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8431685	April 13, 2025	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH INSULIN ALONE OR INSULIN PLUS ONE OTHER ORAL ANTIDIABETIC MEDICATION
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8431685	April 13, 2025	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN AND/OR SULFONYLUREA
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8431685	April 13, 2025	IMPROVING GLYCEMIC CONTROL IN PATIENTS 10 YEARS OF AGE AND OLDER WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING A SUSTAINED-RELEASE EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8461105	April 13, 2025	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH BASAL INSULIN OR BASAL INSULIN PLUS METFORMIN
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8461105	April 13, 2025	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8461105	April 13, 2025	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN, A SULFONYLUREA, A THIAZOLIDINEDIONE, OR COMBINATION OF ANY TWO OF THESE THERAPIES
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8461105	April 13, 2025	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH INSULIN ALONE OR INSULIN PLUS ONE OTHER ORAL ANTIDIABETIC MEDICATION
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8461105	April 13, 2025	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN AND/OR SULFONYLUREA
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8461105	April 13, 2025	IMPROVING GLYCEMIC CONTROL IN PATIENTS 10 YEARS OF AGE AND OLDER WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING A SUSTAINED-RELEASE EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	7612176	April 13, 2025	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH BASAL INSULIN OR BASAL INSULIN PLUS METFORMIN
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	7612176	April 13, 2025	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	7612176	April 13, 2025	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN, A SULFONYLUREA, A THIAZOLIDINEDIONE, OR COMBINATION OF ANY TWO OF THESE THERAPIES
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	7612176	April 13, 2025	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH INSULIN ALONE OR INSULIN PLUS ONE OTHER ORAL ANTIDIABETIC MEDICATION
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	7612176	April 13, 2025	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN AND/OR SULFONYLUREA
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	7612176	April 13, 2025	IMPROVING GLYCEMIC CONTROL IN PATIENTS 10 YEARS OF AGE AND OLDER WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING A SUSTAINED-RELEASE EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8431685	April 13, 2025	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH BASAL INSULIN OR BASAL INSULIN PLUS METFORMIN
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8431685	April 13, 2025	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8431685	April 13, 2025	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN, A SULFONYLUREA, A THIAZOLIDINEDIONE, OR COMBINATION OF ANY TWO OF THESE THERAPIES
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8431685	April 13, 2025	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH INSULIN ALONE OR INSULIN PLUS ONE OTHER ORAL ANTIDIABETIC MEDICATION
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8431685	April 13, 2025	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN AND/OR SULFONYLUREA
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8431685	April 13, 2025	IMPROVING GLYCEMIC CONTROL IN PATIENTS 10 YEARS OF AGE AND OLDER WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING A SUSTAINED-RELEASE EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8461105	April 13, 2025	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH BASAL INSULIN OR BASAL INSULIN PLUS METFORMIN
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8461105	April 13, 2025	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8461105	April 13, 2025	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN, A SULFONYLUREA, A THIAZOLIDINEDIONE, OR COMBINATION OF ANY TWO OF THESE THERAPIES
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8461105	April 13, 2025	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH INSULIN ALONE OR INSULIN PLUS ONE OTHER ORAL ANTIDIABETIC MEDICATION
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8461105	April 13, 2025	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN AND/OR SULFONYLUREA
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8461105	April 13, 2025	IMPROVING GLYCEMIC CONTROL IN PATIENTS 10 YEARS OF AGE AND OLDER WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING A SUSTAINED-RELEASE EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	7612176	April 13, 2025	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH BASAL INSULIN OR BASAL INSULIN PLUS METFORMIN
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	7612176	April 13, 2025	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN, A SULFONYLUREA, A THIAZOLIDINEDIONE, OR COMBINATION OF ANY TWO OF THESE THERAPIES
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	7612176	April 13, 2025	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH INSULIN ALONE OR INSULIN PLUS ONE OTHER ORAL ANTIDIABETIC MEDICATION
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	7612176	April 13, 2025	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN AND/OR SULFONYLUREA
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	7612176	April 13, 2025	IMPROVING GLYCEMIC CONTROL IN PATIENTS 10 YEARS OF AGE AND OLDER WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING A SUSTAINED-RELEASE EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8431685	April 13, 2025	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH BASAL INSULIN OR BASAL INSULIN PLUS METFORMIN
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8431685	April 13, 2025	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8431685	April 13, 2025	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AS ADD-ON TO METFORMIN
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8431685	April 13, 2025	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN, A SULFONYLUREA, A THIAZOLIDINEDIONE, OR COMBINATION OF ANY TWO OF THESE THERAPIES
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8431685	April 13, 2025	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH INSULIN ALONE OR INSULIN PLUS ONE OTHER ORAL ANTIDIABETIC MEDICATION
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8431685	April 13, 2025	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN AND/OR SULFONYLUREA
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8431685	April 13, 2025	IMPROVING GLYCEMIC CONTROL IN PATIENTS 10 YEARS OF AGE AND OLDER WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING A SUSTAINED-RELEASE EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8461105	April 13, 2025	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH BASAL INSULIN OR BASAL INSULIN PLUS METFORMIN
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8461105	April 13, 2025	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8461105	April 13, 2025	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AS ADD-ON TO METFORMIN
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8461105	April 13, 2025	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN, A SULFONYLUREA, A THIAZOLIDINEDIONE, OR COMBINATION OF ANY TWO OF THESE THERAPIES
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8461105	April 13, 2025	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH INSULIN ALONE OR INSULIN PLUS ONE OTHER ORAL ANTIDIABETIC MEDICATION
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8461105	April 13, 2025	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN AND/OR SULFONYLUREA
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8461105	April 13, 2025	IMPROVING GLYCEMIC CONTROL IN PATIENTS 10 YEARS OF AGE AND OLDER WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING A SUSTAINED-RELEASE EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	7456254	June 30, 2025	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH BASAL INSULIN OR BASAL INSULIN PLUS METFORMIN
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	7456254	June 30, 2025	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	7456254	June 30, 2025	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN, A SULFONYLUREA, A THIAZOLIDINEDIONE, OR COMBINATION OF ANY TWO OF THESE THERAPIES
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	7456254	June 30, 2025	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH INSULIN ALONE OR INSULIN PLUS ONE OTHER ORAL ANTIDIABETIC MEDICATION
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	7456254	June 30, 2025	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN AND/OR SULFONYLUREA
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	7456254	June 30, 2025	IMPROVING GLYCEMIC CONTROL IN PATIENTS 10 YEARS OF AGE AND OLDER WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING A SUSTAINED-RELEASE EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	7456254	June 30, 2025	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH BASAL INSULIN OR BASAL INSULIN PLUS METFORMIN
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	7456254	June 30, 2025	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	7456254	June 30, 2025	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN, A SULFONYLUREA, A THIAZOLIDINEDIONE, OR COMBINATION OF ANY TWO OF THESE THERAPIES
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	7456254	June 30, 2025	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH INSULIN ALONE OR INSULIN PLUS ONE OTHER ORAL ANTIDIABETIC MEDICATION
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	7456254	June 30, 2025	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN AND/OR SULFONYLUREA
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	7456254	June 30, 2025	IMPROVING GLYCEMIC CONTROL IN PATIENTS 10 YEARS OF AGE AND OLDER WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING A SUSTAINED-RELEASE EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	7456254	June 30, 2025	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH BASAL INSULIN OR BASAL INSULIN PLUS METFORMIN
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	7456254	June 30, 2025	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	7456254	June 30, 2025	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN, A SULFONYLUREA, A THIAZOLIDINEDIONE, OR COMBINATION OF ANY TWO OF THESE THERAPIES
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	7456254	June 30, 2025	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH INSULIN ALONE OR INSULIN PLUS ONE OTHER ORAL ANTIDIABETIC MEDICATION
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	7456254	June 30, 2025	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN AND/OR SULFONYLUREA
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	7456254	June 30, 2025	IMPROVING GLYCEMIC CONTROL IN PATIENTS 10 YEARS OF AGE AND OLDER WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING A SUSTAINED-RELEASE EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	6515117	Oct. 4, 2025	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	6515117	Oct. 4, 2025	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	6515117	Oct. 4, 2025	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8329648	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH BASAL INSULIN OR BASAL INSULIN PLUS METFORMIN
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8329648	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8329648	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN, A SULFONYLUREA, A THIAZOLIDINEDIONE, OR COMBINATION OF ANY TWO OF THESE THERAPIES
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8329648	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH INSULIN ALONE OR INSULIN PLUS ONE OTHER ORAL ANTIDIABETIC MEDICATION
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8329648	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN AND/OR SULFONYLUREA
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8329648	Aug. 18, 2026	IMPROVING GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8329648	Aug. 18, 2026	IMPROVING GLYCEMIC CONTROL IN PATIENTS 10 YEARS OF AGE AND OLDER WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING A SUSTAINED-RELEASE EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8329648	Aug. 18, 2026	REDUCING BODY WEIGHT IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8329648	Aug. 18, 2026	REDUCING FASTING PLASMA GLUCOSE IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8329648	Aug. 18, 2026	REDUCING HBA1C IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8906851	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH BASAL INSULIN OR BASAL INSULIN PLUS METFORMIN
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8906851	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8906851	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN, A SULFONYLUREA, A THIAZOLIDINEDIONE, OR COMBINATION OF ANY TWO OF THESE THERAPIES
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8906851	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH INSULIN ALONE OR INSULIN PLUS ONE OTHER ORAL ANTIDIABETIC MEDICATION
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8906851	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN AND/OR SULFONYLUREA
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8906851	Aug. 18, 2026	IMPROVING GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8906851	Aug. 18, 2026	IMPROVING GLYCEMIC CONTROL IN PATIENTS 10 YEARS OF AGE AND OLDER WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING A SUSTAINED-RELEASE EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9884092	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH BASAL INSULIN OR BASAL INSULIN PLUS METFORMIN
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9884092	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9884092	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN, A SULFONYLUREA, A THIAZOLIDINEDIONE, OR COMBINATION OF ANY TWO OF THESE THERAPIES
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9884092	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH INSULIN ALONE OR INSULIN PLUS ONE OTHER ORAL ANTIDIABETIC MEDICATION
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9884092	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN AND/OR SULFONYLUREA
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9884092	Aug. 18, 2026	IMPROVING GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9884092	Aug. 18, 2026	IMPROVING GLYCEMIC CONTROL IN PATIENTS 10 YEARS OF AGE AND OLDER WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING A SUSTAINED-RELEASE EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9884092	Aug. 18, 2026	REDUCING BODY WEIGHT IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9884092	Aug. 18, 2026	REDUCING FASTING PLASMA GLUCOSE IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9884092	Aug. 18, 2026	REDUCING HBA1C IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8329648	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH BASAL INSULIN OR BASAL INSULIN PLUS METFORMIN
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8329648	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8329648	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN, A SULFONYLUREA, A THIAZOLIDINEDIONE, OR COMBINATION OF ANY TWO OF THESE THERAPIES
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8329648	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH INSULIN ALONE OR INSULIN PLUS ONE OTHER ORAL ANTIDIABETIC MEDICATION
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8329648	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN AND/OR SULFONYLUREA
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8329648	Aug. 18, 2026	IMPROVING GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8329648	Aug. 18, 2026	IMPROVING GLYCEMIC CONTROL IN PATIENTS 10 YEARS OF AGE AND OLDER WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING A SUSTAINED-RELEASE EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8329648	Aug. 18, 2026	REDUCING BODY WEIGHT IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8329648	Aug. 18, 2026	REDUCING FASTING PLASMA GLUCOSE IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8329648	Aug. 18, 2026	REDUCING HBA1C IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8906851	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH BASAL INSULIN OR BASAL INSULIN PLUS METFORMIN
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8906851	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8906851	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN, A SULFONYLUREA, A THIAZOLIDINEDIONE, OR COMBINATION OF ANY TWO OF THESE THERAPIES
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8906851	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH INSULIN ALONE OR INSULIN PLUS ONE OTHER ORAL ANTIDIABETIC MEDICATION
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8906851	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN AND/OR SULFONYLUREA
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8906851	Aug. 18, 2026	IMPROVING GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8906851	Aug. 18, 2026	IMPROVING GLYCEMIC CONTROL IN PATIENTS 10 YEARS OF AGE AND OLDER WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING A SUSTAINED-RELEASE EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9884092	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH BASAL INSULIN OR BASAL INSULIN PLUS METFORMIN
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9884092	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9884092	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN, A SULFONYLUREA, A THIAZOLIDINEDIONE, OR COMBINATION OF ANY TWO OF THESE THERAPIES
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9884092	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH INSULIN ALONE OR INSULIN PLUS ONE OTHER ORAL ANTIDIABETIC MEDICATION
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9884092	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN AND/OR SULFONYLUREA
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9884092	Aug. 18, 2026	IMPROVING GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9884092	Aug. 18, 2026	IMPROVING GLYCEMIC CONTROL IN PATIENTS 10 YEARS OF AGE AND OLDER WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING A SUSTAINED-RELEASE EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9884092	Aug. 18, 2026	REDUCING BODY WEIGHT IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9884092	Aug. 18, 2026	REDUCING FASTING PLASMA GLUCOSE IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9884092	Aug. 18, 2026	REDUCING HBA1C IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8329648	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH BASAL INSULIN OR BASAL INSULIN PLUS METFORMIN
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8329648	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8329648	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN, A SULFONYLUREA, A THIAZOLIDINEDIONE, OR COMBINATION OF ANY TWO OF THESE THERAPIES
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8329648	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH INSULIN ALONE OR INSULIN PLUS ONE OTHER ORAL ANTIDIABETIC MEDICATION
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8329648	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN AND/OR SULFONYLUREA
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8329648	Aug. 18, 2026	IMPROVING GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8329648	Aug. 18, 2026	IMPROVING GLYCEMIC CONTROL IN PATIENTS 10 YEARS OF AGE AND OLDER WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING A SUSTAINED-RELEASE EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8329648	Aug. 18, 2026	REDUCING BODY WEIGHT IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8329648	Aug. 18, 2026	REDUCING FASTING PLASMA GLUCOSE IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8329648	Aug. 18, 2026	REDUCING HBA1C IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8906851	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH BASAL INSULIN OR BASAL INSULIN PLUS METFORMIN
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8906851	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8906851	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AS ADD-ON TO METFORMIN
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8906851	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN, A SULFONYLUREA, A THIAZOLIDINEDIONE, OR COMBINATION OF ANY TWO OF THESE THERAPIES
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8906851	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH INSULIN ALONE OR INSULIN PLUS ONE OTHER ORAL ANTIDIABETIC MEDICATION
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8906851	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN AND/OR SULFONYLUREA
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8906851	Aug. 18, 2026	IMPROVING GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8906851	Aug. 18, 2026	IMPROVING GLYCEMIC CONTROL IN PATIENTS 10 YEARS OF AGE AND OLDER WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING A SUSTAINED-RELEASE EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9884092	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH BASAL INSULIN OR BASAL INSULIN PLUS METFORMIN
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9884092	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9884092	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AS ADD-ON TO METFORMIN
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9884092	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN, A SULFONYLUREA, A THIAZOLIDINEDIONE, OR COMBINATION OF ANY TWO OF THESE THERAPIES
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9884092	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH INSULIN ALONE OR INSULIN PLUS ONE OTHER ORAL ANTIDIABETIC MEDICATION
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9884092	Aug. 18, 2026	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN AND/OR SULFONYLUREA
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9884092	Aug. 18, 2026	IMPROVING GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9884092	Aug. 18, 2026	IMPROVING GLYCEMIC CONTROL IN PATIENTS 10 YEARS OF AGE AND OLDER WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING A SUSTAINED-RELEASE EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9884092	Aug. 18, 2026	REDUCING BODY WEIGHT IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9884092	Aug. 18, 2026	REDUCING FASTING PLASMA GLUCOSE IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	9884092	Aug. 18, 2026	REDUCING HBA1C IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8501698	June 20, 2027	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8501698	June 20, 2027	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8501698	June 20, 2027	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8361972	March 21, 2028	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8361972	March 21, 2028	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8361972	March 21, 2028	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8895033	Oct. 4, 2030	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH BASAL INSULIN OR BASAL INSULIN PLUS METFORMIN
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8895033	Oct. 4, 2030	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AS ADD-ON TO METFORMIN
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8895033	Oct. 4, 2030	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN, A SULFONYLUREA, A THIAZOLIDINEDIONE, OR COMBINATION OF ANY TWO OF THESE THERAPIES
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8895033	Oct. 4, 2030	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH INSULIN ALONE OR INSULIN PLUS ONE OTHER ORAL ANTIDIABETIC MEDICATION
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8895033	Oct. 4, 2030	AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS 10 TO 17 YEARS OF AGE WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN AND/OR SULFONYLUREA
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8895033	Oct. 4, 2030	DELAYING GASTRIC EMPTYING IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING A PRE-MIXED EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8895033	Oct. 4, 2030	IMPROVING GLYCEMIC CONTROL IN PATIENTS 10 YEARS OF AGE AND OLDER WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING A SUSTAINED-RELEASE EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	8895033	Oct. 4, 2030	STIMULATING INSULIN RELEASE IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING A PRE-MIXED EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	Aug. 15, 2023	PEDIATRIC EXCLUSIVITY
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	Aug. 15, 2023	PEDIATRIC EXCLUSIVITY
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	Aug. 15, 2023	PEDIATRIC EXCLUSIVITY
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	July 22, 2024	NEW PATIENT POPULATION
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	July 22, 2024	NEW PATIENT POPULATION
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	July 22, 2024	NEW PATIENT POPULATION
300MCG/1.2ML (250MCG/ML)	BYETTA	ASTRAZENECA AB	N021773	April 28, 2005	RX	INJECTABLE	SUBCUTANEOUS	Nov. 4, 2024	INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO DESCRIBE THE RESULTS FROM PEDIATRIC STUDIES
600MCG/2.4ML (250MCG/ML)	BYETTA	ASTRAZENECA AB	N021773	April 28, 2005	RX	INJECTABLE	SUBCUTANEOUS	Nov. 4, 2024	INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO DESCRIBE THE RESULTS FROM PEDIATRIC STUDIES
2MG	BYDUREON PEN	ASTRAZENECA AB	N022200	Feb. 28, 2014	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	Jan. 22, 2025	PEDIATRIC EXCLUSIVITY
2MG/VIAL	BYDUREON	ASTRAZENECA AB	N022200	Jan. 27, 2012	DISCN	FOR SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	Jan. 22, 2025	PEDIATRIC EXCLUSIVITY
2MG/0.85ML (2MG/0.85ML)	BYDUREON BCISE	ASTRAZENECA AB	N209210	Oct. 20, 2017	RX	SUSPENSION, EXTENDED RELEASE	SUBCUTANEOUS	Jan. 22, 2025	PEDIATRIC EXCLUSIVITY

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Glucagon-like peptide 1 receptor	GPCR	P43220	GLP1R_HUMAN	AGONIST	IC50	9.18		CHEMBL	CHEMBL
Glucagon-like peptide 1 receptor	GPCR		GLP1R_RAT		IC50	9.85		CHEMBL

External reference:

ID	Source
4024921	VUID
N0000171592	NUI
D04121	KEGG_DRUG
4024921	VANDF
C0167117	UMLSCUI
CHEBI:64073	CHEBI
CHEMBL414357	ChEMBL_ID
D000077270	MESH_DESCRIPTOR_UI
DB01276	DRUGBANK_ID
8219	INN_ID
9P1872D4OL	UNII
45588096	PUBCHEM_CID
1242964	RXNORM
184698	MMSL
19812	MMSL
d05529	MMSL
010772	NDDF
416859008	SNOMEDCT_US
417734003	SNOMEDCT_US
CHEMBL1210015	ChEMBL_ID
1135	IUPHAR_LIGAND_ID

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Byetta	HUMAN PRESCRIPTION DRUG LABEL	1	0310-6512	INJECTION	250 ug	SUBCUTANEOUS	NDA	29 sections
Byetta	HUMAN PRESCRIPTION DRUG LABEL	1	0310-6512	INJECTION	250 ug	SUBCUTANEOUS	NDA	29 sections
Byetta	HUMAN PRESCRIPTION DRUG LABEL	1	0310-6512	INJECTION	250 ug	SUBCUTANEOUS	NDA	29 sections
Byetta	HUMAN PRESCRIPTION DRUG LABEL	1	0310-6524	INJECTION	250 ug	SUBCUTANEOUS	NDA	29 sections
Byetta	HUMAN PRESCRIPTION DRUG LABEL	1	0310-6524	INJECTION	250 ug	SUBCUTANEOUS	NDA	29 sections
Byetta	HUMAN PRESCRIPTION DRUG LABEL	1	0310-6524	INJECTION	250 ug	SUBCUTANEOUS	NDA	29 sections
BYDUREON	HUMAN PRESCRIPTION DRUG LABEL	1	0310-6530	INJECTION, SUSPENSION, EXTENDED RELEASE	2 mg	SUBCUTANEOUS	NDA	29 sections
BYDUREON	HUMAN PRESCRIPTION DRUG LABEL	1	0310-6530	INJECTION, SUSPENSION, EXTENDED RELEASE	2 mg	SUBCUTANEOUS	NDA	29 sections
BYDUREON	HUMAN PRESCRIPTION DRUG LABEL	1	0310-6530	INJECTION, SUSPENSION, EXTENDED RELEASE	2 mg	SUBCUTANEOUS	NDA	29 sections
BYDUREON BCise	HUMAN PRESCRIPTION DRUG LABEL	1	0310-6540	INJECTION, SUSPENSION, EXTENDED RELEASE	2 mg	SUBCUTANEOUS	NDA	29 sections
BYDUREON BCise	HUMAN PRESCRIPTION DRUG LABEL	1	0310-6540	INJECTION, SUSPENSION, EXTENDED RELEASE	2 mg	SUBCUTANEOUS	NDA	29 sections
BYDUREON BCise	HUMAN PRESCRIPTION DRUG LABEL	1	0310-6540	INJECTION, SUSPENSION, EXTENDED RELEASE	2 mg	SUBCUTANEOUS	NDA	29 sections
BYDUREON BCise	HUMAN PRESCRIPTION DRUG LABEL	1	0310-6540	INJECTION, SUSPENSION, EXTENDED RELEASE	2 mg	SUBCUTANEOUS	NDA	29 sections
BYETTA	HUMAN PRESCRIPTION DRUG LABEL	1	54868-5384	INJECTION	250 ug	SUBCUTANEOUS	NDA	30 sections