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

Stem definition	Drug id	CAS RN
	4399	496775-61-2

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: eltrombopag SB 497115 revolade eltrombopag olamine ppromacta	an oral, nonpeptide thrombopoietin receptor agonist Molecular weight: 442.48 Formula: C25H22N4O4 CLOGP: 5.25 LIPINSKI: 1 HAC: 8 HDO: 3 TPSA: 114.59 ALOGS: -4.63 ROTB: 5 Status: ONP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

eltrombopag
SB 497115
revolade
eltrombopag olamine
ppromacta

an oral, nonpeptide thrombopoietin receptor agonist

Molecular weight: 442.48
Formula: C25H22N4O4
CLOGP: 5.25
LIPINSKI: 1
HAC: 8
HDO: 3
TPSA: 114.59
ALOGS: -4.63
ROTB: 5

Status: ONP

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

Drug dosage:

Dose	Unit	Route
50	mg	O

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Hosey CM, Chan R, Benet LZ

Approvals:

Date	Agency	Company	Orphan
March 11, 2010	EMA
Nov. 20, 2008	FDA	NOVARTIS PHARMS CORP

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
Platelet count decreased	1116.59	19.71	504	10336	100222	50494062
Death	391.64	19.71	410	10430	324969	50269315
Platelet count increased	351.48	19.71	128	10712	14412	50579872
Thrombocytopenia	181.93	19.71	177	10663	127496	50466788
Myelofibrosis	164.02	19.71	40	10800	1107	50593177
Product use in unapproved indication	160.15	19.71	158	10682	115661	50478623
Platelet count abnormal	144.93	19.71	44	10796	2805	50591479
Haemorrhage	124.22	19.71	98	10742	53343	50540941
Thrombocytosis	116.97	19.71	43	10797	4953	50589331
Bone marrow reticulin fibrosis	109.40	19.71	20	10820	125	50594159
Petechiae	102.03	19.71	51	10789	12461	50581823
Thrombosis	74.84	19.71	75	10765	55758	50538526
Immune thrombocytopenia	74.24	19.71	37	10803	8980	50585304
Gingival bleeding	71.71	19.71	39	10801	11314	50582970
Transplant dysfunction	69.59	19.71	29	10811	4655	50589629
Pulmonary embolism	66.93	19.71	95	10745	101609	50492675
Cerebral infarction	62.06	19.71	45	10795	21559	50572725
Therapy non-responder	58.41	19.71	63	10777	50959	50543325
Haemoglobin decreased	57.51	19.71	100	10740	127116	50467168
Mucosal haemorrhage	52.26	19.71	15	10825	785	50593499
Mouth haemorrhage	49.75	19.71	25	10815	6171	50588113
Concomitant disease aggravated	48.90	19.71	27	10813	8064	50586220
Platelet disorder	46.68	19.71	16	10824	1501	50592783
Drug ineffective	45.67	19.71	315	10525	819018	49775266
Epistaxis	45.41	19.71	62	10778	63892	50530392
Acute graft versus host disease	44.08	19.71	20	10820	3938	50590346
Portal vein thrombosis	40.80	19.71	16	10824	2196	50592088
Cytogenetic analysis abnormal	39.99	19.71	12	10828	734	50593550
Antiphospholipid syndrome	39.02	19.71	14	10826	1503	50592781
Haemorrhage intracranial	38.35	19.71	27	10813	12347	50581937
Deep vein thrombosis	37.58	19.71	61	10779	73243	50521041
Paroxysmal nocturnal haemoglobinuria	36.44	19.71	8	10832	137	50594147
Bone marrow myelogram abnormal	35.46	19.71	6	10834	22	50594262
Clonal evolution	35.19	19.71	7	10833	72	50594212
Drug hypersensitivity	34.72	19.71	6	10834	251004	50343280
Liver disorder	34.16	19.71	41	10799	37181	50557103
Pain	33.68	19.71	45	10795	578858	50015426
Acute myeloid leukaemia	33.59	19.71	27	10813	15047	50579237
Myelodysplastic syndrome	33.50	19.71	27	10813	15105	50579179
Cytomegalovirus infection	33.45	19.71	29	10811	17933	50576351
Cerebral venous thrombosis	32.64	19.71	13	10827	1858	50592426
Rheumatoid arthritis	32.45	19.71	3	10837	202547	50391737
White blood cell count increased	31.57	19.71	42	10798	42198	50552086
Marrow hyperplasia	29.72	19.71	9	10831	568	50593716
Myalgia	29.40	19.71	75	10765	124244	50470040
Aplastic anaemia	29.09	19.71	19	10821	7684	50586600
Heavy menstrual bleeding	28.76	19.71	25	10815	15512	50578772
Cerebral haemorrhage	28.51	19.71	32	10808	27020	50567264
Blast cell count increased	28.46	19.71	8	10832	388	50593896
Hepatic infection	27.54	19.71	8	10832	437	50593847
Chronic lymphocytic leukaemia	26.65	19.71	12	10828	2321	50591963
Headache	25.26	19.71	190	10650	506345	50087939
Therapeutic response decreased	25.14	19.71	40	10800	47191	50547093
Blood bilirubin increased	22.63	19.71	31	10809	32007	50562277
Leukocytosis	22.59	19.71	26	10814	22553	50571731
Cytogenetic abnormality	22.52	19.71	7	10833	482	50593802
Adenocarcinoma gastric	22.37	19.71	7	10833	493	50593791
Spleen operation	22.35	19.71	3	10837	0	50594284
Disease progression	21.79	19.71	57	10783	95809	50498475
Megakaryocytes abnormal	21.01	19.71	4	10836	32	50594252
Contusion	20.86	19.71	62	10778	112121	50482163
Subdural haematoma	20.35	19.71	19	10821	12928	50581356
Blast cell proliferation	20.27	19.71	3	10837	3	50594281
Megakaryocytes increased	20.12	19.71	4	10836	41	50594243

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
Platelet count decreased	618.32	19.55	370	7593	104302	29462262
Death	390.63	19.55	466	7497	341618	29224946
Platelet count increased	168.88	19.55	69	7894	8394	29558170
Immune thrombocytopenia	149.62	19.55	62	7901	7815	29558749
Platelet count abnormal	146.83	19.55	45	7918	2349	29564215
Product use in unapproved indication	127.59	19.55	136	7827	86739	29479825
Myelofibrosis	109.19	19.55	32	7931	1430	29565134
Drug ineffective	106.00	19.55	272	7691	362898	29203666
Acute myeloid leukaemia	68.39	19.55	47	7916	16466	29550098
Myelodysplastic syndrome	65.22	19.55	47	7916	17747	29548817
Haematological malignancy	56.81	19.55	14	7949	319	29566245
Therapy non-responder	55.43	19.55	54	7909	30857	29535707
Bone marrow reticulin fibrosis	54.88	19.55	12	7951	158	29566406
Disease progression	54.71	19.55	87	7876	81829	29484735
Platelet disorder	52.56	19.55	18	7945	1337	29565227
Liver disorder	45.17	19.55	46	7917	27703	29538861
Epistaxis	44.68	19.55	62	7901	51642	29514922
Gingival bleeding	43.43	19.55	25	7938	6428	29560136
Petechiae	41.75	19.55	27	7936	8544	29558020
Clonal evolution	40.85	19.55	9	7954	123	29566441
Cytogenetic abnormality	40.23	19.55	13	7950	806	29565758
Thrombocytopenia	39.95	19.55	102	7861	134721	29431843
Thrombocytosis	39.81	19.55	19	7944	3334	29563230
Haemorrhage	38.86	19.55	54	7909	45018	29521546
Hypoparathyroidism	29.44	19.55	9	7954	465	29566099
Mucosal haemorrhage	28.95	19.55	12	7951	1509	29565055
Paroxysmal nocturnal haemoglobinuria	26.99	19.55	5	7958	26	29566538
Toxicity to various agents	26.57	19.55	7	7956	173654	29392910
Contusion	26.41	19.55	37	7926	31058	29535506
Blast cell count increased	22.88	19.55	9	7954	988	29565576
Serum sickness	20.95	19.55	10	7953	1755	29564809
Chronic myelomonocytic leukaemia	20.01	19.55	7	7956	554	29566010

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
Platelet count decreased	1098.50	17.00	599	14099	167112	64316922
Death	583.55	17.00	627	14071	482078	64001956
Platelet count increased	308.92	17.00	127	14571	18569	64465465
Myelofibrosis	237.52	17.00	62	14636	2131	64481903
Product use in unapproved indication	226.57	17.00	238	14460	176380	64307654
Platelet count abnormal	182.33	17.00	58	14640	4054	64479980
Immune thrombocytopenia	178.68	17.00	81	14617	14985	64469049
Petechiae	165.26	17.00	82	14616	18544	64465490
Haemorrhage	137.09	17.00	126	14572	79225	64404809
Thrombocytopenia	136.23	17.00	208	14490	223593	64260441
Thrombocytosis	133.23	17.00	53	14645	7103	64476931
Bone marrow reticulin fibrosis	112.49	17.00	23	14675	257	64483777
Acute myeloid leukaemia	105.42	17.00	70	14628	27393	64456641
Drug ineffective	100.80	17.00	417	14281	839830	63644204
Gingival bleeding	93.53	17.00	52	14646	14802	64469232
Myelodysplastic syndrome	93.26	17.00	65	14633	27514	64456520
Transplant dysfunction	85.68	17.00	38	14660	6670	64477364
Epistaxis	79.99	17.00	105	14593	98026	64386008
Therapy non-responder	77.53	17.00	85	14613	65814	64418220
Mucosal haemorrhage	76.27	17.00	26	14672	2255	64481779
Clonal evolution	75.74	17.00	16	14682	212	64483822
Haemoglobin decreased	67.70	17.00	142	14556	194921	64289113
Cytogenetic abnormality	64.30	17.00	19	14679	1035	64482999
Disease progression	62.33	17.00	114	14584	141566	64342468
Liver disorder	56.22	17.00	65	14633	53286	64430748
Acute graft versus host disease	55.00	17.00	31	14667	9053	64474981
Platelet disorder	53.48	17.00	20	14678	2267	64481767
Pulmonary embolism	52.45	17.00	108	14590	146248	64337786
Cerebral infarction	50.10	17.00	54	14644	40990	64443044
Haematological malignancy	47.24	17.00	13	14685	547	64483487
Concomitant disease aggravated	45.68	17.00	30	14668	11512	64472522
Deep vein thrombosis	45.43	17.00	84	14614	105098	64378936
Cerebral haemorrhage	45.25	17.00	57	14641	51033	64433001
Paroxysmal nocturnal haemoglobinuria	44.63	17.00	10	14688	177	64483857
Chronic lymphocytic leukaemia	41.25	17.00	20	14678	4295	64479739
White blood cell count increased	40.92	17.00	62	14636	65952	64418082
Contusion	40.69	17.00	84	14614	113881	64370153
Toxicity to various agents	39.06	17.00	17	14681	363496	64120538
Cerebral venous thrombosis	38.31	17.00	16	14682	2425	64481609
Thrombosis	37.77	17.00	62	14636	70580	64413454
Mouth haemorrhage	37.59	17.00	25	14673	9794	64474240
Haemorrhagic diathesis	36.62	17.00	20	14678	5494	64478540
Pain	36.03	17.00	44	14654	553467	63930567
Bone marrow myelogram abnormal	35.31	17.00	7	14691	66	64483968
Cytomegalovirus infection	32.14	17.00	41	14657	37158	64446876
Haemorrhage intracranial	31.94	17.00	33	14665	23851	64460183
Portal vein thrombosis	30.12	17.00	17	14681	4974	64479060
Ecchymosis	29.64	17.00	25	14673	13997	64470037
Hepatic infection	29.60	17.00	10	14688	843	64483191
Blast cell count increased	29.23	17.00	11	14687	1268	64482766
Megakaryocytes abnormal	27.71	17.00	6	14692	90	64483944
Blood bilirubin increased	27.43	17.00	48	14650	57505	64426529
Splenectomy	27.42	17.00	9	14689	694	64483340
Chronic graft versus host disease	26.52	17.00	17	14681	6259	64477775
Heavy menstrual bleeding	26.50	17.00	22	14676	12055	64471979
Sepsis	25.49	17.00	112	14586	230229	64253805
Hypoparathyroidism	25.37	17.00	9	14689	878	64483156
Serum sickness	25.23	17.00	13	14685	3176	64480858
Hospitalisation	25.16	17.00	54	14644	75153	64408881
Infusion related reaction	24.57	17.00	4	14694	164463	64319571
Chronic myeloid leukaemia	24.54	17.00	13	14685	3361	64480673
Hospice care	23.52	17.00	17	14681	7608	64476426
Acute leukaemia	23.50	17.00	10	14688	1588	64482446
Dyspnoea	23.24	17.00	85	14613	718589	63765445
Hypotension	22.98	17.00	32	14666	380942	64103092
Therapeutic response decreased	22.92	17.00	42	14656	52146	64431888
Chronic myelomonocytic leukaemia	22.89	17.00	8	14690	747	64483287
Drug hypersensitivity	22.69	17.00	13	14685	237802	64246232
Concomitant disease progression	22.10	17.00	12	14686	3257	64480777
Joint swelling	21.68	17.00	11	14687	215371	64268663
Pyrexia	21.15	17.00	207	14491	558437	63925597
Mean platelet volume increased	20.87	17.00	8	14690	970	64483064
White blood cell count decreased	20.80	17.00	81	14617	157756	64326278
Aplastic anaemia	20.01	17.00	20	14678	13900	64470134
Evans syndrome	19.08	17.00	6	14692	403	64483631
Febrile neutropenia	19.07	17.00	89	14609	187568	64296466
Oral mucosa haematoma	19.00	17.00	4	14694	52	64483982
Pneumonia	18.63	17.00	202	14496	559374	63924660
Marrow hyperplasia	18.19	17.00	8	14690	1376	64482658
Myeloproliferative neoplasm	18.00	17.00	7	14691	882	64483152
Overdose	17.86	17.00	7	14691	159559	64324475
Reticulin increased	17.54	17.00	3	14695	11	64484023
Bradycardia	17.37	17.00	3	14695	118216	64365818
Platelet glycoprotein gene mutation	17.34	17.00	3	14695	12	64484022
Cytogenetic analysis abnormal	17.33	17.00	7	14691	974	64483060
Leukaemia	17.21	17.00	12	14686	5076	64478958
Antiphospholipid syndrome	17.16	17.00	8	14690	1574	64482460
Therapy partial responder	17.13	17.00	16	14682	10232	64473802

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	B02BX05	BLOOD AND BLOOD FORMING ORGANS ANTIHEMORRHAGICS VITAMIN K AND OTHER HEMOSTATICS Other systemic hemostatics
FDA MoA	N0000175968	Thrombopoietin Receptor Agonists
FDA PE	N0000175969	Increased Megakaryocyte Maturation
FDA PE	N0000175970	Increased Platelet Production
FDA EPC	N0000175973	Thrombopoietin Receptor Agonist
FDA MoA	N0000190107	Organic Anion Transporting Polypeptide 1B1 Inhibitors
FDA MoA	N0000190113	Breast Cancer Resistance Protein Inhibitors
FDA MoA	N0000191272	UGT1A1 Inhibitors
FDA MoA	N0000191273	UGT2B7 Inhibitors
FDA MoA	N0000191274	UGT2B15 Inhibitors
FDA MoA	N0000191275	UGT1A3 Inhibitors
FDA MoA	N0000191276	UGT1A4 Inhibitors
FDA MoA	N0000191277	UGT1A6 Inhibitors
FDA MoA	N0000191278	UGT1A9 Inhibitors

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

Disease	Relation	SNOMED_ID	DOID
Chronic idiopathic thrombocytopenic purpura	indication	13172003
Thrombocytosis	contraindication	6631009	DOID:2228
Hyperbilirubinemia	contraindication	14783006	DOID:2741
Acute hepatitis	contraindication	37871000
Hepatic vein thrombosis	contraindication	38739001	DOID:11512
Leukopenia	contraindication	84828003	DOID:615
Kidney disease	contraindication	90708001	DOID:557
Bilateral cataracts	contraindication	95722004
Myelodysplastic syndrome	contraindication	109995007
Liver function tests abnormal	contraindication	166603001
Acute hepatic failure	contraindication	197270009
Disease of liver	contraindication	235856003	DOID:409
Anemia	contraindication	271737000	DOID:2355
Thromboembolic disorder	contraindication	371039008
Increased Reticulin Bone Marrow Deposition	contraindication
Predisposition to Thrombosis	contraindication

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	3.16	acidic
pKa2	3.76	acidic
pKa3	10.67	acidic
pKa4	1.34	Basic
pKa5	0.59	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
EQ 100MG ACID Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	PROMACTA	NOVARTIS	N022291	Nov. 16, 2012	DISCN	TABLET	ORAL	7160870	Nov. 20, 2022	PATIENTS WITH SEVERE APLASTIC ANEMIA WHO HAVE HAD AN INSUFFICIENT RESPONSE TO IMMUNOSUPPRESSIVE THERAPY
EQ 100MG ACID Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	PROMACTA	NOVARTIS	N022291	Nov. 16, 2012	DISCN	TABLET	ORAL	7160870	Nov. 20, 2022	TREATMENT OF IDIOPATHIC THROMBOCYTOPENIC PURPURA (ITP)
EQ 100MG ACID Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	PROMACTA	NOVARTIS	N022291	Nov. 16, 2012	DISCN	TABLET	ORAL	7160870	Nov. 20, 2022	TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 6 YEARS AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
EQ 100MG ACID Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	PROMACTA	NOVARTIS	N022291	Nov. 16, 2012	DISCN	TABLET	ORAL	7160870	Nov. 20, 2022	TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY
EQ 12.5MG ACID	PROMACTA	NOVARTIS	N022291	Oct. 20, 2011	RX	TABLET	ORAL	7160870	Nov. 20, 2022	TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
EQ 12.5MG ACID	PROMACTA	NOVARTIS	N022291	Oct. 20, 2011	RX	TABLET	ORAL	7160870	Nov. 20, 2022	TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY
EQ 25MG ACID	PROMACTA	NOVARTIS	N022291	Nov. 20, 2008	RX	TABLET	ORAL	7160870	Nov. 20, 2022	TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
EQ 25MG ACID	PROMACTA	NOVARTIS	N022291	Nov. 20, 2008	RX	TABLET	ORAL	7160870	Nov. 20, 2022	TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY
EQ 50MG ACID	PROMACTA	NOVARTIS	N022291	Nov. 20, 2008	RX	TABLET	ORAL	7160870	Nov. 20, 2022	TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
EQ 50MG ACID	PROMACTA	NOVARTIS	N022291	Nov. 20, 2008	RX	TABLET	ORAL	7160870	Nov. 20, 2022	TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY
EQ 75MG ACID	PROMACTA	NOVARTIS	N022291	Sept. 8, 2009	RX	TABLET	ORAL	7160870	Nov. 20, 2022	TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
EQ 75MG ACID	PROMACTA	NOVARTIS	N022291	Sept. 8, 2009	RX	TABLET	ORAL	7160870	Nov. 20, 2022	TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY
EQ 12.5MG ACID/PACKET	PROMACTA KIT	NOVARTIS	N207027	Sept. 27, 2018	RX	FOR SUSPENSION	ORAL	7160870	Nov. 20, 2022	TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
EQ 12.5MG ACID/PACKET	PROMACTA KIT	NOVARTIS	N207027	Sept. 27, 2018	RX	FOR SUSPENSION	ORAL	7160870	Nov. 20, 2022	TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY
EQ 25MG ACID/PACKET	PROMACTA KIT	NOVARTIS	N207027	Aug. 24, 2015	RX	FOR SUSPENSION	ORAL	7160870	Nov. 20, 2022	TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
EQ 25MG ACID/PACKET	PROMACTA KIT	NOVARTIS	N207027	Aug. 24, 2015	RX	FOR SUSPENSION	ORAL	7160870	Nov. 20, 2022	TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY
EQ 100MG ACID Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	PROMACTA	NOVARTIS	N022291	Nov. 16, 2012	DISCN	TABLET	ORAL	7795293	May 21, 2023	PATIENTS WITH SEVERE APLASTIC ANEMIA WHO HAVE HAD AN INSUFFICIENT RESPONSE TO IMMUNOSUPPRESSIVE THERAPY
EQ 100MG ACID Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	PROMACTA	NOVARTIS	N022291	Nov. 16, 2012	DISCN	TABLET	ORAL	7795293	May 21, 2023	TREATMENT OF IDIOPATHIC THROMBOCYTOPENIC PURPURA (ITP)
EQ 100MG ACID Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	PROMACTA	NOVARTIS	N022291	Nov. 16, 2012	DISCN	TABLET	ORAL	7795293	May 21, 2023	TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY
EQ 12.5MG ACID	PROMACTA	NOVARTIS	N022291	Oct. 20, 2011	RX	TABLET	ORAL	7795293	May 21, 2023	TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
EQ 12.5MG ACID	PROMACTA	NOVARTIS	N022291	Oct. 20, 2011	RX	TABLET	ORAL	7795293	May 21, 2023	TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY
EQ 25MG ACID	PROMACTA	NOVARTIS	N022291	Nov. 20, 2008	RX	TABLET	ORAL	7795293	May 21, 2023	TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
EQ 25MG ACID	PROMACTA	NOVARTIS	N022291	Nov. 20, 2008	RX	TABLET	ORAL	7795293	May 21, 2023	TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY
EQ 50MG ACID	PROMACTA	NOVARTIS	N022291	Nov. 20, 2008	RX	TABLET	ORAL	7795293	May 21, 2023	TREATMENT OF IDIOPATHIC THROMBOCYTOPENIC PURPURA (ITP)
EQ 50MG ACID	PROMACTA	NOVARTIS	N022291	Nov. 20, 2008	RX	TABLET	ORAL	7795293	May 21, 2023	TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
EQ 50MG ACID	PROMACTA	NOVARTIS	N022291	Nov. 20, 2008	RX	TABLET	ORAL	7795293	May 21, 2023	TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY
EQ 75MG ACID	PROMACTA	NOVARTIS	N022291	Sept. 8, 2009	RX	TABLET	ORAL	7795293	May 21, 2023	TREATMENT OF IDIOPATHIC THROMBOCYTOPENIC PURPURA (ITP)
EQ 75MG ACID	PROMACTA	NOVARTIS	N022291	Sept. 8, 2009	RX	TABLET	ORAL	7795293	May 21, 2023	TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
EQ 75MG ACID	PROMACTA	NOVARTIS	N022291	Sept. 8, 2009	RX	TABLET	ORAL	7795293	May 21, 2023	TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY
EQ 12.5MG ACID/PACKET	PROMACTA KIT	NOVARTIS	N207027	Sept. 27, 2018	RX	FOR SUSPENSION	ORAL	7795293	May 21, 2023	TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
EQ 12.5MG ACID/PACKET	PROMACTA KIT	NOVARTIS	N207027	Sept. 27, 2018	RX	FOR SUSPENSION	ORAL	7795293	May 21, 2023	TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY
EQ 25MG ACID/PACKET	PROMACTA KIT	NOVARTIS	N207027	Aug. 24, 2015	RX	FOR SUSPENSION	ORAL	7795293	May 21, 2023	TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
EQ 25MG ACID/PACKET	PROMACTA KIT	NOVARTIS	N207027	Aug. 24, 2015	RX	FOR SUSPENSION	ORAL	7795293	May 21, 2023	TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY
EQ 100MG ACID Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	PROMACTA	NOVARTIS	N022291	Nov. 16, 2012	DISCN	TABLET	ORAL	7547719	July 13, 2025	PATIENTS WITH SEVERE APLASTIC ANEMIA WHO HAVE HAD AN INSUFFICIENT RESPONSE TO IMMUNOSUPPRESSIVE THERAPY
EQ 100MG ACID Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	PROMACTA	NOVARTIS	N022291	Nov. 16, 2012	DISCN	TABLET	ORAL	7547719	July 13, 2025	TREATMENT OF IDIOPATHIC THROMBOCYTOPENIC PURPURA (ITP)
EQ 100MG ACID Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	PROMACTA	NOVARTIS	N022291	Nov. 16, 2012	DISCN	TABLET	ORAL	7547719	July 13, 2025	TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY
EQ 12.5MG ACID	PROMACTA	NOVARTIS	N022291	Oct. 20, 2011	RX	TABLET	ORAL	7547719	July 13, 2025	COMBINATION WITH IMMUNOSUPPRESSIVE THERAPY FOR FIRST-LINE TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS AND OLDER WITH SEVERE APLASTIC ANEMIA
EQ 12.5MG ACID	PROMACTA	NOVARTIS	N022291	Oct. 20, 2011	RX	TABLET	ORAL	7547719	July 13, 2025	PATIENTS WITH SEVERE APLASTIC ANEMIA WHO HAVE HAD AN INSUFFICIENT RESPONSE TO IMMUNOSUPPRESSIVE THERAPY
EQ 12.5MG ACID	PROMACTA	NOVARTIS	N022291	Oct. 20, 2011	RX	TABLET	ORAL	7547719	July 13, 2025	TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
EQ 12.5MG ACID	PROMACTA	NOVARTIS	N022291	Oct. 20, 2011	RX	TABLET	ORAL	7547719	July 13, 2025	TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY
EQ 25MG ACID	PROMACTA	NOVARTIS	N022291	Nov. 20, 2008	RX	TABLET	ORAL	7547719	July 13, 2025	COMBINATION WITH IMMUNOSUPPRESSIVE THERAPY FOR FIRST-LINE TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS AND OLDER WITH SEVERE APLASTIC ANEMIA
EQ 25MG ACID	PROMACTA	NOVARTIS	N022291	Nov. 20, 2008	RX	TABLET	ORAL	7547719	July 13, 2025	PATIENTS WITH SEVERE APLASTIC ANEMIA WHO HAVE HAD AN INSUFFICIENT RESPONSE TO IMMUNOSUPPRESSIVE THERAPY
EQ 25MG ACID	PROMACTA	NOVARTIS	N022291	Nov. 20, 2008	RX	TABLET	ORAL	7547719	July 13, 2025	TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
EQ 25MG ACID	PROMACTA	NOVARTIS	N022291	Nov. 20, 2008	RX	TABLET	ORAL	7547719	July 13, 2025	TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY
EQ 50MG ACID	PROMACTA	NOVARTIS	N022291	Nov. 20, 2008	RX	TABLET	ORAL	7547719	July 13, 2025	COMBINATION WITH IMMUNOSUPPRESSIVE THERAPY FOR FIRST-LINE TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS AND OLDER WITH SEVERE APLASTIC ANEMIA
EQ 50MG ACID	PROMACTA	NOVARTIS	N022291	Nov. 20, 2008	RX	TABLET	ORAL	7547719	July 13, 2025	PATIENTS WITH SEVERE APLASTIC ANEMIA WHO HAVE HAD AN INSUFFICIENT RESPONSE TO IMMUNOSUPPRESSIVE THERAPY
EQ 50MG ACID	PROMACTA	NOVARTIS	N022291	Nov. 20, 2008	RX	TABLET	ORAL	7547719	July 13, 2025	TREATMENT OF IDIOPATHIC THROMBOCYTOPENIC PURPURA (ITP)
EQ 50MG ACID	PROMACTA	NOVARTIS	N022291	Nov. 20, 2008	RX	TABLET	ORAL	7547719	July 13, 2025	TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
EQ 50MG ACID	PROMACTA	NOVARTIS	N022291	Nov. 20, 2008	RX	TABLET	ORAL	7547719	July 13, 2025	TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY
EQ 75MG ACID	PROMACTA	NOVARTIS	N022291	Sept. 8, 2009	RX	TABLET	ORAL	7547719	July 13, 2025	COMBINATION WITH IMMUNOSUPPRESSIVE THERAPY FOR FIRST-LINE TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS AND OLDER WITH SEVERE APLASTIC ANEMIA
EQ 75MG ACID	PROMACTA	NOVARTIS	N022291	Sept. 8, 2009	RX	TABLET	ORAL	7547719	July 13, 2025	PATIENTS WITH SEVERE APLASTIC ANEMIA WHO HAVE HAD AN INSUFFICIENT RESPONSE TO IMMUNOSUPPRESSIVE THERAPY
EQ 75MG ACID	PROMACTA	NOVARTIS	N022291	Sept. 8, 2009	RX	TABLET	ORAL	7547719	July 13, 2025	TREATMENT OF IDIOPATHIC THROMBOCYTOPENIC PURPURA (ITP)
EQ 75MG ACID	PROMACTA	NOVARTIS	N022291	Sept. 8, 2009	RX	TABLET	ORAL	7547719	July 13, 2025	TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
EQ 75MG ACID	PROMACTA	NOVARTIS	N022291	Sept. 8, 2009	RX	TABLET	ORAL	7547719	July 13, 2025	TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY
EQ 12.5MG ACID/PACKET	PROMACTA KIT	NOVARTIS	N207027	Sept. 27, 2018	RX	FOR SUSPENSION	ORAL	7547719	July 13, 2025	COMBINATION WITH IMMUNOSUPPRESSIVE THERAPY FOR FIRST-LINE TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS AND OLDER WITH SEVERE APLASTIC ANEMIA
EQ 12.5MG ACID/PACKET	PROMACTA KIT	NOVARTIS	N207027	Sept. 27, 2018	RX	FOR SUSPENSION	ORAL	7547719	July 13, 2025	PATIENTS WITH SEVERE APLASTIC ANEMIA WHO HAVE HAD AN INSUFFICIENT RESPONSE TO IMMUNOSUPPRESSIVE THERAPY
EQ 12.5MG ACID/PACKET	PROMACTA KIT	NOVARTIS	N207027	Sept. 27, 2018	RX	FOR SUSPENSION	ORAL	7547719	July 13, 2025	TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
EQ 12.5MG ACID/PACKET	PROMACTA KIT	NOVARTIS	N207027	Sept. 27, 2018	RX	FOR SUSPENSION	ORAL	7547719	July 13, 2025	TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY
EQ 25MG ACID/PACKET	PROMACTA KIT	NOVARTIS	N207027	Aug. 24, 2015	RX	FOR SUSPENSION	ORAL	7547719	July 13, 2025	COMBINATION WITH IMMUNOSUPPRESSIVE THERAPY FOR FIRST-LINE TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS AND OLDER WITH SEVERE APLASTIC ANEMIA
EQ 25MG ACID/PACKET	PROMACTA KIT	NOVARTIS	N207027	Aug. 24, 2015	RX	FOR SUSPENSION	ORAL	7547719	July 13, 2025	PATIENTS WITH SEVERE APLASTIC ANEMIA WHO HAVE HAD AN INSUFFICIENT RESPONSE TO IMMUNOSUPPRESSIVE THERAPY
EQ 25MG ACID/PACKET	PROMACTA KIT	NOVARTIS	N207027	Aug. 24, 2015	RX	FOR SUSPENSION	ORAL	7547719	July 13, 2025	TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
EQ 25MG ACID/PACKET	PROMACTA KIT	NOVARTIS	N207027	Aug. 24, 2015	RX	FOR SUSPENSION	ORAL	7547719	July 13, 2025	TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY
EQ 12.5MG ACID	PROMACTA	NOVARTIS	N022291	Oct. 20, 2011	RX	TABLET	ORAL	8052993	Aug. 1, 2027	TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 6 YEARS AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
EQ 12.5MG ACID	PROMACTA	NOVARTIS	N022291	Oct. 20, 2011	RX	TABLET	ORAL	8052994	Aug. 1, 2027	TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 6 YEARS AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
EQ 12.5MG ACID	PROMACTA	NOVARTIS	N022291	Oct. 20, 2011	RX	TABLET	ORAL	8062665	Aug. 1, 2027	TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 6 YEARS AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
EQ 12.5MG ACID	PROMACTA	NOVARTIS	N022291	Oct. 20, 2011	RX	TABLET	ORAL	8071129	Aug. 1, 2027	TREATMENT OF IDIOPATHIC THROMBOCYTOPENIC PURPURA (ITP)
EQ 12.5MG ACID	PROMACTA	NOVARTIS	N022291	Oct. 20, 2011	RX	TABLET	ORAL	8071129	Aug. 1, 2027	TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
EQ 12.5MG ACID	PROMACTA	NOVARTIS	N022291	Oct. 20, 2011	RX	TABLET	ORAL	8071129	Aug. 1, 2027	TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY
EQ 12.5MG ACID	PROMACTA	NOVARTIS	N022291	Oct. 20, 2011	RX	TABLET	ORAL	8828430	Aug. 1, 2027	TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
EQ 12.5MG ACID	PROMACTA	NOVARTIS	N022291	Oct. 20, 2011	RX	TABLET	ORAL	8828430	Aug. 1, 2027	TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY
EQ 25MG ACID	PROMACTA	NOVARTIS	N022291	Nov. 20, 2008	RX	TABLET	ORAL	8052993	Aug. 1, 2027	PATIENTS WITH SEVERE APLASTIC ANEMIA WHO HAVE HAD AN INSUFFICIENT RESPONSE TO IMMUNOSUPPRESSIVE THERAPY
EQ 25MG ACID	PROMACTA	NOVARTIS	N022291	Nov. 20, 2008	RX	TABLET	ORAL	8052993	Aug. 1, 2027	TREATMENT OF IDIOPATHIC THROMBOCYTOPENIC PURPURA (ITP)
EQ 25MG ACID	PROMACTA	NOVARTIS	N022291	Nov. 20, 2008	RX	TABLET	ORAL	8052993	Aug. 1, 2027	TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
EQ 25MG ACID	PROMACTA	NOVARTIS	N022291	Nov. 20, 2008	RX	TABLET	ORAL	8052993	Aug. 1, 2027	TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY
EQ 25MG ACID	PROMACTA	NOVARTIS	N022291	Nov. 20, 2008	RX	TABLET	ORAL	8052994	Aug. 1, 2027	TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 6 YEARS AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
EQ 25MG ACID	PROMACTA	NOVARTIS	N022291	Nov. 20, 2008	RX	TABLET	ORAL	8062665	Aug. 1, 2027	TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 6 YEARS AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
EQ 25MG ACID	PROMACTA	NOVARTIS	N022291	Nov. 20, 2008	RX	TABLET	ORAL	8071129	Aug. 1, 2027	TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 6 YEARS AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
EQ 25MG ACID	PROMACTA	NOVARTIS	N022291	Nov. 20, 2008	RX	TABLET	ORAL	8828430	Aug. 1, 2027	TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
EQ 25MG ACID	PROMACTA	NOVARTIS	N022291	Nov. 20, 2008	RX	TABLET	ORAL	8828430	Aug. 1, 2027	TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY
EQ 50MG ACID	PROMACTA	NOVARTIS	N022291	Nov. 20, 2008	RX	TABLET	ORAL	8052993	Aug. 1, 2027	TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 6 YEARS AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
EQ 50MG ACID	PROMACTA	NOVARTIS	N022291	Nov. 20, 2008	RX	TABLET	ORAL	8052994	Aug. 1, 2027	TREATMENT OF IDIOPATHIC THROMBOCYTOPENIC PURPURA (ITP)
EQ 50MG ACID	PROMACTA	NOVARTIS	N022291	Nov. 20, 2008	RX	TABLET	ORAL	8052994	Aug. 1, 2027	TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
EQ 50MG ACID	PROMACTA	NOVARTIS	N022291	Nov. 20, 2008	RX	TABLET	ORAL	8052994	Aug. 1, 2027	TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY
EQ 50MG ACID	PROMACTA	NOVARTIS	N022291	Nov. 20, 2008	RX	TABLET	ORAL	8062665	Aug. 1, 2027	TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 6 YEARS AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
EQ 50MG ACID	PROMACTA	NOVARTIS	N022291	Nov. 20, 2008	RX	TABLET	ORAL	8071129	Aug. 1, 2027	TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 6 YEARS AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
EQ 50MG ACID	PROMACTA	NOVARTIS	N022291	Nov. 20, 2008	RX	TABLET	ORAL	8828430	Aug. 1, 2027	TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
EQ 50MG ACID	PROMACTA	NOVARTIS	N022291	Nov. 20, 2008	RX	TABLET	ORAL	8828430	Aug. 1, 2027	TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY
EQ 75MG ACID	PROMACTA	NOVARTIS	N022291	Sept. 8, 2009	RX	TABLET	ORAL	8052993	Aug. 1, 2027	TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 6 YEARS AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
EQ 75MG ACID	PROMACTA	NOVARTIS	N022291	Sept. 8, 2009	RX	TABLET	ORAL	8052994	Aug. 1, 2027	TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 6 YEARS AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
EQ 75MG ACID	PROMACTA	NOVARTIS	N022291	Sept. 8, 2009	RX	TABLET	ORAL	8062665	Aug. 1, 2027	TREATMENT OF IDIOPATHIC THROMBOCYTOPENIC PURPURA (ITP)
EQ 75MG ACID	PROMACTA	NOVARTIS	N022291	Sept. 8, 2009	RX	TABLET	ORAL	8062665	Aug. 1, 2027	TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
EQ 75MG ACID	PROMACTA	NOVARTIS	N022291	Sept. 8, 2009	RX	TABLET	ORAL	8062665	Aug. 1, 2027	TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY
EQ 75MG ACID	PROMACTA	NOVARTIS	N022291	Sept. 8, 2009	RX	TABLET	ORAL	8071129	Aug. 1, 2027	TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 6 YEARS AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
EQ 75MG ACID	PROMACTA	NOVARTIS	N022291	Sept. 8, 2009	RX	TABLET	ORAL	8828430	Aug. 1, 2027	TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
EQ 75MG ACID	PROMACTA	NOVARTIS	N022291	Sept. 8, 2009	RX	TABLET	ORAL	8828430	Aug. 1, 2027	TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
EQ 100MG ACID Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	PROMACTA	NOVARTIS	N022291	Nov. 16, 2012	DISCN	TABLET	ORAL	Feb. 26, 2022	PEDIATRIC EXCLUSIVITY
EQ 12.5MG ACID	PROMACTA	NOVARTIS	N022291	Oct. 20, 2011	RX	TABLET	ORAL	Feb. 26, 2022	PEDIATRIC EXCLUSIVITY
EQ 25MG ACID	PROMACTA	NOVARTIS	N022291	Nov. 20, 2008	RX	TABLET	ORAL	Feb. 26, 2022	PEDIATRIC EXCLUSIVITY
EQ 50MG ACID	PROMACTA	NOVARTIS	N022291	Nov. 20, 2008	RX	TABLET	ORAL	Feb. 26, 2022	PEDIATRIC EXCLUSIVITY
EQ 75MG ACID	PROMACTA	NOVARTIS	N022291	Sept. 8, 2009	RX	TABLET	ORAL	Feb. 26, 2022	PEDIATRIC EXCLUSIVITY
EQ 12.5MG ACID/PACKET	PROMACTA KIT	NOVARTIS	N207027	Sept. 27, 2018	RX	FOR SUSPENSION	ORAL	Feb. 26, 2022	PEDIATRIC EXCLUSIVITY
EQ 25MG ACID/PACKET	PROMACTA KIT	NOVARTIS	N207027	Aug. 24, 2015	RX	FOR SUSPENSION	ORAL	Feb. 26, 2022	PEDIATRIC EXCLUSIVITY
EQ 100MG ACID Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	PROMACTA	NOVARTIS	N022291	Nov. 16, 2012	DISCN	TABLET	ORAL	Nov. 16, 2025	INDICATED IN COMBINATION WITH STANDARD IMMUNOSUPPRESSIVE THERAPY FOR THE FIRST-LINE TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS AND OLDER WITH SEVERE APLASTIC ANEMIA
EQ 12.5MG ACID	PROMACTA	NOVARTIS	N022291	Oct. 20, 2011	RX	TABLET	ORAL	Nov. 16, 2025	INDICATED IN COMBINATION WITH STANDARD IMMUNOSUPPRESSIVE THERAPY FOR THE FIRST-LINE TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS AND OLDER WITH SEVERE APLASTIC ANEMIA
EQ 25MG ACID	PROMACTA	NOVARTIS	N022291	Nov. 20, 2008	RX	TABLET	ORAL	Nov. 16, 2025	INDICATED IN COMBINATION WITH STANDARD IMMUNOSUPPRESSIVE THERAPY FOR THE FIRST-LINE TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS AND OLDER WITH SEVERE APLASTIC ANEMIA
EQ 50MG ACID	PROMACTA	NOVARTIS	N022291	Nov. 20, 2008	RX	TABLET	ORAL	Nov. 16, 2025	INDICATED IN COMBINATION WITH STANDARD IMMUNOSUPPRESSIVE THERAPY FOR THE FIRST-LINE TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS AND OLDER WITH SEVERE APLASTIC ANEMIA
EQ 75MG ACID	PROMACTA	NOVARTIS	N022291	Sept. 8, 2009	RX	TABLET	ORAL	Nov. 16, 2025	INDICATED IN COMBINATION WITH STANDARD IMMUNOSUPPRESSIVE THERAPY FOR THE FIRST-LINE TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS AND OLDER WITH SEVERE APLASTIC ANEMIA
EQ 12.5MG ACID/PACKET	PROMACTA KIT	NOVARTIS	N207027	Sept. 27, 2018	RX	FOR SUSPENSION	ORAL	Nov. 16, 2025	FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
EQ 25MG ACID/PACKET	PROMACTA KIT	NOVARTIS	N207027	Aug. 24, 2015	RX	FOR SUSPENSION	ORAL	Nov. 16, 2025	FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Thrombopoietin receptor	Membrane receptor	P40238	TPOR_HUMAN	AGONIST	EC50	7.42		IUPHAR	IUPHAR
Potassium voltage-gated channel subfamily H member 2	Ion channel	Q12809	KCNH2_HUMAN		IC50	6.16		CHEMBL

External reference:

ID	Source
D03978	KEGG_DRUG
4028105	VUID
N0000179799	NUI
496775-62-3	SECONDARY_CAS_RN
4028105	VANDF
C1831905	UMLSCUI
CHEMBL461101	ChEMBL_ID
CHEMBL461806	ChEMBL_ID
CHEMBL3989691	ChEMBL_ID
DB06210	DRUGBANK_ID
C520809	MESH_SUPPLEMENTAL_RECORD_UI
6961	IUPHAR_LIGAND_ID
8655	INN_ID
S56D65XJ9G	UNII
135449332	PUBCHEM_CID
711942	RXNORM
d07357	MMSL
012912	NDDF
012913	NDDF
432005001	SNOMEDCT_US
434132009	SNOMEDCT_US
441995009	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
PROMACTA	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0684	TABLET, FILM COATED	12.50 mg	ORAL	NDA	33 sections
PROMACTA	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0684	TABLET, FILM COATED	12.50 mg	ORAL	NDA	33 sections
PROMACTA	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0685	TABLET, FILM COATED	25 mg	ORAL	NDA	33 sections
PROMACTA	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0685	TABLET, FILM COATED	25 mg	ORAL	NDA	33 sections
PROMACTA	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0686	TABLET, FILM COATED	50 mg	ORAL	NDA	33 sections
PROMACTA	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0686	TABLET, FILM COATED	50 mg	ORAL	NDA	33 sections
PROMACTA	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0687	TABLET, FILM COATED	75 mg	ORAL	NDA	33 sections
PROMACTA	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0687	TABLET, FILM COATED	75 mg	ORAL	NDA	33 sections
PROMACTA	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0697	POWDER, FOR SUSPENSION	25 mg	ORAL	NDA	33 sections
PROMACTA	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0697	POWDER, FOR SUSPENSION	25 mg	ORAL	NDA	33 sections
PROMACTA	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0972	POWDER, FOR SUSPENSION	12.50 mg	ORAL	NDA	33 sections
PROMACTA	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0972	POWDER, FOR SUSPENSION	12.50 mg	ORAL	NDA	33 sections