dapagliflozin Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
sodium glucose co-transporter inhibitors, phlorizin derivatives	4304	461432-26-8

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: dapagliflozin propanediol monohydrate dapagliflozin propanediol BMS 512148 forxiga dapaglifozin dapagliflozin farxiga dapagliflozin propylene glycolate hydrate	an Sodium-glucose cotransporter 2 (SGLT2) inhibitor, SGLT2 expressed in the proximal renal tubules, is responsible for the majority of the reabsorption of filtered glucose from the tubular lumen, by inhibiting SGLT2, dapagliflozin reduces reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion Molecular weight: 408.88 Formula: C21H25ClO6 CLOGP: 3.37 LIPINSKI: 0 HAC: 6 HDO: 4 TPSA: 99.38 ALOGS: -3.37 ROTB: 6 Status: ONP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

dapagliflozin propanediol monohydrate
dapagliflozin propanediol
BMS 512148
forxiga
dapaglifozin
dapagliflozin
farxiga
dapagliflozin propylene glycolate hydrate

an Sodium-glucose cotransporter 2 (SGLT2) inhibitor, SGLT2 expressed in the proximal renal tubules, is responsible for the majority of the reabsorption of filtered glucose from the tubular lumen, by inhibiting SGLT2, dapagliflozin reduces reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion

Molecular weight: 408.88
Formula: C21H25ClO6
CLOGP: 3.37
LIPINSKI: 0
HAC: 6
HDO: 4
TPSA: 99.38
ALOGS: -3.37
ROTB: 6

Status: ONP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
10	mg	O

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Hosey CM, Chan R, Benet LZ
Vd (Volume of distribution)	1.70 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	3 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.09 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	12.20 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
Nov. 12, 2012	EMA
Jan. 8, 2014	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
Diabetic ketoacidosis	3004.63	21.16	690	8057	17520	46659795
Ketoacidosis	1192.10	21.16	247	8500	3708	46673607
Euglycaemic diabetic ketoacidosis	648.30	21.16	133	8614	1883	46675432
Fungal infection	338.56	21.16	146	8601	29374	46647941
Glycosylated haemoglobin increased	162.33	21.16	65	8682	10811	46666504
Diabetes mellitus inadequate control	140.36	21.16	62	8685	13152	46664163
Blood glucose increased	118.27	21.16	102	8645	71911	46605404
Ketosis	115.97	21.16	25	8722	452	46676863
Urinary tract infection	100.27	21.16	161	8586	220105	46457210
Ketonuria	97.98	21.16	21	8726	369	46676946
Diabetic metabolic decompensation	79.36	21.16	22	8725	1163	46676152
Metabolic acidosis	78.36	21.16	62	8685	38718	46638597
Blood ketone body increased	75.59	21.16	16	8731	264	46677051
Weight decreased	66.03	21.16	131	8616	210718	46466597
Hyperglycaemia	64.34	21.16	53	8694	35018	46642297
Urine ketone body present	62.53	21.16	21	8726	2121	46675194
Hypoglycaemia	60.34	21.16	62	8685	54287	46623028
Pyelonephritis	52.90	21.16	34	8713	15323	46661992
Pruritus genital	52.62	21.16	14	8733	633	46676682
Temperature perception test abnormal	51.55	21.16	8	8739	17	46677298
Genital infection female	50.92	21.16	10	8737	111	46677204
Urosepsis	48.02	21.16	32	8715	15321	46661994
Dehydration	46.15	21.16	96	8651	159444	46517871
Glucose urine present	42.82	21.16	12	8735	660	46676655
Vulvovaginal pruritus	41.31	21.16	16	8731	2431	46674884
Genital infection fungal	40.88	21.16	9	8738	180	46677135
Polyuria	40.81	21.16	22	8725	7173	46670142
Acute kidney injury	40.44	21.16	116	8631	235739	46441576
Necrotising fasciitis	40.23	21.16	16	8731	2607	46674708
Genital infection	37.82	21.16	7	8740	55	46677260
Lactic acidosis	34.60	21.16	37	8710	33872	46643443
Candida infection	33.43	21.16	30	8717	22210	46655105
Glomerular filtration rate decreased	33.29	21.16	23	8724	11671	46665644
Decreased vibratory sense	32.36	21.16	8	8739	269	46677046
Acidosis	31.86	21.16	22	8725	11152	46666163
Cerebral infarction	30.24	21.16	29	8718	23337	46653978
Pyelonephritis acute	30.24	21.16	15	8732	4119	46673196
Toe amputation	29.84	21.16	12	8735	2012	46675303
Pollakiuria	29.32	21.16	29	8718	24232	46653083
Haematuria	28.63	21.16	30	8717	26828	46650487
Hyperglycaemic hyperosmolar nonketotic syndrome	27.20	21.16	8	8739	523	46676792
Rheumatoid arthritis	27.00	21.16	6	8741	240209	46437106
Vulvovaginal mycotic infection	26.63	21.16	14	8733	4337	46672978
Blood ketone body	26.61	21.16	5	8742	43	46677272
Compartment syndrome	26.56	21.16	11	8736	1988	46675327
Diabetic ketosis	24.96	21.16	6	8741	179	46677136
Diabetic ketoacidotic hyperglycaemic coma	24.46	21.16	5	8742	69	46677246
Dysuria	24.31	21.16	28	8719	27805	46649510
Capillary leak syndrome	23.73	21.16	10	8737	1887	46675428
Vulvovaginitis	21.96	21.16	6	8741	300	46677015
Glycosuria	21.64	21.16	8	8739	1070	46676245

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
Diabetic ketoacidosis	2194.30	19.69	571	8216	15415	29928276
Ketoacidosis	720.25	19.69	176	8611	3570	29940121
Euglycaemic diabetic ketoacidosis	411.21	19.69	98	8689	1773	29941918
Glycosylated haemoglobin increased	188.41	19.69	79	8708	9412	29934279
Ketonuria	160.89	19.69	37	8750	567	29943124
Phimosis	137.63	19.69	33	8754	611	29943080
Balanoposthitis	125.48	19.69	34	8753	1042	29942649
Fungal infection	104.10	19.69	59	8728	13541	29930150
Blood glucose increased	103.72	19.69	108	8679	61422	29882269
Ketosis	94.35	19.69	22	8765	359	29943332
Weight decreased	93.21	19.69	162	8625	150759	29792932
Diabetes mellitus inadequate control	91.34	19.69	53	8734	12709	29930982
Bladder cancer	90.58	19.69	47	8740	9055	29934636
Lactic acidosis	90.03	19.69	74	8713	31139	29912552
Polyuria	85.20	19.69	42	8745	7264	29936427
Metabolic acidosis	84.15	19.69	77	8710	37384	29906307
Hyperglycaemia	82.29	19.69	74	8713	35126	29908565
Urinary tract infection	79.84	19.69	103	8684	73556	29870135
Toe amputation	70.31	19.69	26	8761	2215	29941476
Acquired phimosis	64.31	19.69	12	8775	59	29943632
Epididymitis	62.23	19.69	24	8763	2295	29941396
Dehydration	60.32	19.69	120	8667	123419	29820272
Necrotising fasciitis	56.22	19.69	25	8762	3424	29940267
Pollakiuria	54.92	19.69	43	8744	16863	29926828
Hypoglycaemia	54.72	19.69	71	8716	50910	29892781
Blood ketone body increased	54.01	19.69	14	8773	360	29943331
Urine ketone body present	52.68	19.69	17	8770	962	29942729
Cerebral infarction	49.28	19.69	49	8738	26324	29917367
Blood glucose abnormal	49.01	19.69	26	8761	5233	29938458
Diabetic ketosis	48.27	19.69	9	8778	44	29943647
Blood triglycerides increased	46.28	19.69	36	8751	13981	29929710
Glucose urine present	45.42	19.69	15	8772	913	29942778
Acute kidney injury	43.69	19.69	177	8610	273665	29670026
Glomerular filtration rate decreased	41.51	19.69	31	8756	11331	29932360
Hyperglycaemic hyperosmolar nonketotic syndrome	40.78	19.69	14	8773	960	29942731
Thrombotic cerebral infarction	37.26	19.69	10	8777	295	29943396
Pancreatitis	33.31	19.69	47	8740	36443	29907248
Glycosuria	33.16	19.69	13	8774	1298	29942393
Pancreatitis acute	32.70	19.69	39	8748	25656	29918035
Blood cholesterol increased	32.56	19.69	32	8755	16938	29926753
Thirst	32.40	19.69	22	8765	6927	29936764
Haematuria	28.67	19.69	49	8738	44785	29898906
Urosepsis	27.92	19.69	24	8763	10708	29932983
Genital rash	27.87	19.69	9	8778	510	29943181
Neutropenia	27.18	19.69	3	8784	128537	29815154
Dysuria	26.70	19.69	33	8754	22508	29921183
Acetonaemia	26.26	19.69	6	8781	89	29943602
Acute myocardial infarction	25.24	19.69	51	8736	52888	29890803
Foot amputation	24.55	19.69	8	8779	467	29943224
Type 2 diabetes mellitus	23.04	19.69	24	8763	13598	29930093
Brain stem infarction	23.01	19.69	10	8777	1296	29942395
Thrombocytopenia	22.86	19.69	6	8781	137038	29806653
Pyelonephritis	22.53	19.69	16	8771	5410	29938281
Toxicity to various agents	22.48	19.69	12	8775	177171	29766520
Genital infection fungal	22.07	19.69	6	8781	186	29943505
Urine output increased	21.62	19.69	9	8778	1049	29942642
Peripheral circulatory failure	21.48	19.69	6	8781	206	29943485
Immune-mediated hepatitis	21.16	19.69	9	8778	1107	29942584
Gangrene	20.07	19.69	14	8773	4600	29939091
Anaemia	19.95	19.69	19	8768	207973	29735718

Pharmacologic Action:

Source	Code	Description
ATC	A10BD15	ALIMENTARY TRACT AND METABOLISM DRUGS USED IN DIABETES BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS Combinations of oral blood glucose lowering drugs
ATC	A10BD21	ALIMENTARY TRACT AND METABOLISM DRUGS USED IN DIABETES BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS Combinations of oral blood glucose lowering drugs
ATC	A10BD25	ALIMENTARY TRACT AND METABOLISM DRUGS USED IN DIABETES BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS Combinations of oral blood glucose lowering drugs
ATC	A10BK01	ALIMENTARY TRACT AND METABOLISM DRUGS USED IN DIABETES BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS Sodium-glucose co-transporter 2 (SGLT2) inhibitors
MeSH PA	D007004	Hypoglycemic Agents
MeSH PA	D000077203	Sodium-Glucose Transporter 2 Inhibitors
FDA MoA	N0000187058	Sodium-Glucose Transporter 2 Inhibitors
FDA EPC	N0000187059	Sodium-Glucose Cotransporter 2 Inhibitor
CHEBI has role	CHEBI:35526	hypoglycemic drug
CHEBI has role	CHEBI:73273	sodium glucose co-transporter 2 inhibitor

Drug Use (View source of the data)

Disease	Relation	SNOMED_ID	DOID
Diabetes mellitus type 2	indication	44054006	DOID:9352

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	11.62	acidic
pKa2	13.26	acidic
pKa3	13.7	acidic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
10MG	FARXIGA	ASTRAZENECA AB	N202293	Jan. 8, 2014	RX	TABLET	ORAL	Feb. 22, 2022	INFORMATION ADDED TO THE PRESCRIBING INFORMATION TO REFLECT THAT NO DOSE ADJUSTMENT IS NEEDED FOR PATIENTS WITH AN ESTIMATED GLOMERULAR FILTRATION RATE (EGFR) OF 45 ML/MIN/1.73 M2 OR GREATER AS SUPPORTED BY CLINICAL STUDY REPORT
5MG	FARXIGA	ASTRAZENECA AB	N202293	Jan. 8, 2014	RX	TABLET	ORAL	Feb. 22, 2022	INFORMATION ADDED TO THE PRESCRIBING INFORMATION TO REFLECT THAT NO DOSE ADJUSTMENT IS NEEDED FOR PATIENTS WITH AN ESTIMATED GLOMERULAR FILTRATION RATE (EGFR) OF 45 ML/MIN/1.73 M2 OR GREATER AS SUPPORTED BY CLINICAL STUDY REPORT
10MG;EQ 5MG BASE	QTERN	ASTRAZENECA AB	N209091	Feb. 27, 2017	RX	TABLET	ORAL	May 2, 2022	EXPANDED INDICATION FOR USE AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS
5MG;EQ 5MG BASE	QTERN	ASTRAZENECA AB	N209091	May 2, 2019	RX	TABLET	ORAL	May 2, 2022	NEW STRENGTH
10MG;1GM;EQ 5MG BASE	QTERNMET XR	ASTRAZENECA AB	N210874	May 2, 2019	DISCN	TABLET, EXTENDED RELEASE	ORAL	May 2, 2022	NEW PRODUCT
2.5MG;1GM;EQ 2.5MG BASE	QTERNMET XR	ASTRAZENECA AB	N210874	May 2, 2019	DISCN	TABLET, EXTENDED RELEASE	ORAL	May 2, 2022	NEW PRODUCT
5MG;1GM;EQ 2.5MG BASE	QTERNMET XR	ASTRAZENECA AB	N210874	May 2, 2019	DISCN	TABLET, EXTENDED RELEASE	ORAL	May 2, 2022	NEW PRODUCT
5MG;1GM;EQ 5MG BASE	QTERNMET XR	ASTRAZENECA AB	N210874	May 2, 2019	DISCN	TABLET, EXTENDED RELEASE	ORAL	May 2, 2022	NEW PRODUCT
10MG	FARXIGA	ASTRAZENECA AB	N202293	Jan. 8, 2014	RX	TABLET	ORAL	Oct. 18, 2022	TO REDUCE THE RISK OF HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH TYPE 2 DIABETES MELLITUS AND ESTABLISHED CARDIOVASCULAR DISEASE OR MULTIPLE CARDIOVASCULAR RISK FACTORS
5MG	FARXIGA	ASTRAZENECA AB	N202293	Jan. 8, 2014	RX	TABLET	ORAL	Oct. 18, 2022	TO REDUCE THE RISK OF HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH TYPE 2 DIABETES MELLITUS AND ESTABLISHED CARDIOVASCULAR DISEASE OR MULTIPLE CARDIOVASCULAR RISK FACTORS
10MG;1GM	XIGDUO XR	ASTRAZENECA AB	N205649	Oct. 29, 2014	RX	TABLET, EXTENDED RELEASE	ORAL	Oct. 18, 2022	TO REDUCE THE RISK OF HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH TYPE 2 DIABETES MELLITUS AND ESTABLISHED CARDIOVASCULAR DISEASE OR MULTIPLE CARDIOVASCULAR RISK FACTORS
10MG;500MG	XIGDUO XR	ASTRAZENECA AB	N205649	Oct. 29, 2014	RX	TABLET, EXTENDED RELEASE	ORAL	Oct. 18, 2022	TO REDUCE THE RISK OF HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH TYPE 2 DIABETES MELLITUS AND ESTABLISHED CARDIOVASCULAR DISEASE OR MULTIPLE CARDIOVASCULAR RISK FACTORS
2.5MG;1GM	XIGDUO XR	ASTRAZENECA AB	N205649	July 28, 2017	RX	TABLET, EXTENDED RELEASE	ORAL	Oct. 18, 2022	TO REDUCE THE RISK OF HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH TYPE 2 DIABETES MELLITUS AND ESTABLISHED CARDIOVASCULAR DISEASE OR MULTIPLE CARDIOVASCULAR RISK FACTORS
5MG;1GM	XIGDUO XR	ASTRAZENECA AB	N205649	Oct. 29, 2014	RX	TABLET, EXTENDED RELEASE	ORAL	Oct. 18, 2022	TO REDUCE THE RISK OF HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH TYPE 2 DIABETES MELLITUS AND ESTABLISHED CARDIOVASCULAR DISEASE OR MULTIPLE CARDIOVASCULAR RISK FACTORS
5MG;500MG	XIGDUO XR	ASTRAZENECA AB	N205649	Oct. 29, 2014	RX	TABLET, EXTENDED RELEASE	ORAL	Oct. 18, 2022	TO REDUCE THE RISK OF HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH TYPE 2 DIABETES MELLITUS AND ESTABLISHED CARDIOVASCULAR DISEASE OR MULTIPLE CARDIOVASCULAR RISK FACTORS
10MG	FARXIGA	ASTRAZENECA AB	N202293	Jan. 8, 2014	RX	TABLET	ORAL	May 5, 2023	TO REDUCE THE RISK OF CARDIOVASCULAR DEATH AND HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH HEART FAILURE (NYHA CLASS II-IV) WITH REDUCED EJECTION FRACTION
5MG	FARXIGA	ASTRAZENECA AB	N202293	Jan. 8, 2014	RX	TABLET	ORAL	May 5, 2023	TO REDUCE THE RISK OF CARDIOVASCULAR DEATH AND HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH HEART FAILURE (NYHA CLASS II-IV) WITH REDUCED EJECTION FRACTION
10MG	FARXIGA	ASTRAZENECA AB	N202293	Jan. 8, 2014	RX	TABLET	ORAL	April 30, 2024	TO REDUCE THE RISK OF SUSTAINED EGFR DECLINE, END-STAGE KIDNEY DISEASE, CARDIOVASCULAR DEATH, AND HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH CHRONIC KIDNEY DISEASE AT RISK OF PROGRESSION
5MG	FARXIGA	ASTRAZENECA AB	N202293	Jan. 8, 2014	RX	TABLET	ORAL	April 30, 2024	TO REDUCE THE RISK OF SUSTAINED EGFR DECLINE, END-STAGE KIDNEY DISEASE, CARDIOVASCULAR DEATH, AND HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH CHRONIC KIDNEY DISEASE AT RISK OF PROGRESSION

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Sodium/glucose cotransporter 2	Transporter	P31639	SC5A2_HUMAN	INHIBITOR	IC50	9.30	IUPHAR	IUPHAR
Low affinity sodium-glucose cotransporter	Transporter	Q9NY91	SC5A4_HUMAN		IC50	8.87	CHEMBL
Sodium/glucose cotransporter 1	Transporter	P13866	SC5A1_HUMAN		IC50	8.49	CHEMBL
Sodium/myo-inositol cotransporter 2	Transporter	Q8WWX8	SC5AB_HUMAN		IC50	6.42	CHEMBL
Sodium/glucose cotransporter 2	Transporter		SC5A2_RAT		EC50	8.52	CHEMBL

External reference:

ID	Source
D08897	KEGG_DRUG
960404-48-2	SECONDARY_CAS_RN
4033035	VANDF
C2353950	UMLSCUI
CHEBI:85078	CHEBI
CHEMBL429910	ChEMBL_ID
CHEMBL2103802	ChEMBL_ID
DB06292	DRUGBANK_ID
C529054	MESH_SUPPLEMENTAL_RECORD_UI
9887712	PUBCHEM_CID
4594	IUPHAR_LIGAND_ID
8886	INN_ID
1ULL0QJ8UC	UNII
1486966	RXNORM
210769	MMSL
28989	MMSL
29986	MMSL
d07928	MMSL
014949	NDDF
014950	NDDF
703674001	SNOMEDCT_US
703675000	SNOMEDCT_US
703678003	SNOMEDCT_US
783086004	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
FARXIGA	HUMAN PRESCRIPTION DRUG LABEL	1	0310-6205	TABLET, FILM COATED	5 mg	ORAL	NDA	27 sections
FARXIGA	HUMAN PRESCRIPTION DRUG LABEL	1	0310-6210	TABLET, FILM COATED	10 mg	ORAL	NDA	27 sections
XIGDUOXR	HUMAN PRESCRIPTION DRUG LABEL	2	0310-6225	TABLET, FILM COATED, EXTENDED RELEASE	2.50 mg	ORAL	NDA	30 sections
XIGDUOXR	HUMAN PRESCRIPTION DRUG LABEL	2	0310-6250	TABLET, FILM COATED, EXTENDED RELEASE	5 mg	ORAL	NDA	30 sections
XIGDUOXR	HUMAN PRESCRIPTION DRUG LABEL	2	0310-6260	TABLET, FILM COATED, EXTENDED RELEASE	5 mg	ORAL	NDA	30 sections
XIGDUOXR	HUMAN PRESCRIPTION DRUG LABEL	2	0310-6270	TABLET, FILM COATED, EXTENDED RELEASE	10 mg	ORAL	NDA	30 sections
XIGDUOXR	HUMAN PRESCRIPTION DRUG LABEL	2	0310-6280	TABLET, FILM COATED, EXTENDED RELEASE	10 mg	ORAL	NDA	30 sections
QTERN	HUMAN PRESCRIPTION DRUG LABEL	2	0310-6770	TABLET, FILM COATED	5 mg	ORAL	NDA	28 sections
QTERN	HUMAN PRESCRIPTION DRUG LABEL	2	0310-6780	TABLET, FILM COATED	10 mg	ORAL	NDA	28 sections
FARXIGA	HUMAN PRESCRIPTION DRUG LABEL	1	50090-3481	TABLET, FILM COATED	10 mg	ORAL	NDA	27 sections
FARXIGA	HUMAN PRESCRIPTION DRUG LABEL	1	50090-3482	TABLET, FILM COATED	5 mg	ORAL	NDA	27 sections
FARXIGA	HUMAN PRESCRIPTION DRUG LABEL	1	55154-6932	TABLET, FILM COATED	5 mg	ORAL	NDA	28 sections
FARXIGA	HUMAN PRESCRIPTION DRUG LABEL	1	55154-6933	TABLET, FILM COATED	10 mg	ORAL	NDA	28 sections