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

Stem definitionDrug idCAS RN
4399 496775-61-2

Description:

MoleculeDescription

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:

DoseUnitRoute
50 mg O

ADMET properties:

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

Approvals:

DateAgencyCompanyOrphan
March 11, 2010 EMA
Nov. 20, 2008 FDA NOVARTIS PHARMS CORP

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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 termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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 termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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:

SourceCodeDescription
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 (View source of the data)

DiseaseRelationSNOMED_IDDOID
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 levelDissociation constantType (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 strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent 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 strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
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:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Thrombopoietin receptor Membrane receptor AGONIST EC50 7.42 IUPHAR IUPHAR
Potassium voltage-gated channel subfamily H member 2 Ion channel IC50 6.16 CHEMBL

External reference:

IDSource
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:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
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