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

Stem definitionDrug idCAS RN
thrombopoietin agonists 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: OFP
    • 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
S (Water solubility) 0.00 mg/mL Bocci G, Oprea TI, Benet LZ
fu (Fraction unbound in plasma) 0 % Kawashima H, Watanabe R, Esaki T, Kuroda M, Nagao C, Natsume-Kitatani Y, Ohashi R, Komura H, Mizuguchi K

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 1511.80 18.31 643 12444 115479 63360456
Death 488.25 18.31 484 12603 373897 63102038
Platelet count increased 404.39 18.31 148 12939 17563 63458372
Platelet count abnormal 212.93 18.31 61 13026 3303 63472632
Product use in unapproved indication 210.91 18.31 220 12867 178860 63297075
Thrombocytopenia 196.66 18.31 196 12891 150961 63324974
Myelofibrosis 188.41 18.31 46 13041 1331 63474604
Haemorrhage 159.17 18.31 118 12969 60904 63415031
Petechiae 119.45 18.31 58 13029 13839 63462096
Thrombocytosis 119.40 18.31 45 13042 5773 63470162
Bone marrow reticulin fibrosis 101.75 18.31 20 13067 201 63475734
Gingival bleeding 91.82 18.31 47 13040 12540 63463395
Immune thrombocytopenia 81.62 18.31 41 13046 10515 63465420
Thrombosis 80.39 18.31 82 13005 64673 63411262
Haemoglobin decreased 73.93 18.31 118 12969 145367 63330568
Pulmonary embolism 72.57 18.31 104 12983 116580 63359355
Therapy non-responder 69.65 18.31 82 13005 75819 63400116
Transplant dysfunction 69.56 18.31 29 13058 4843 63471092
Cerebral infarction 64.02 18.31 47 13040 23846 63452089
Mouth haemorrhage 57.34 18.31 28 13059 6755 63469180
Antiphospholipid syndrome 56.27 18.31 19 13068 1771 63474164
Concomitant disease aggravated 55.03 18.31 30 13057 9082 63466853
Drug ineffective 53.96 18.31 383 12704 1044382 62431553
Mucosal haemorrhage 52.04 18.31 16 13071 1105 63474830
Epistaxis 51.44 18.31 69 13018 72656 63403279
Platelet disorder 51.16 18.31 18 13069 1898 63474037
Paroxysmal nocturnal haemoglobinuria 49.16 18.31 11 13076 215 63475720
Portal vein thrombosis 45.60 18.31 18 13069 2612 63473323
Pain 42.92 18.31 54 13033 740574 62735361
Acute graft versus host disease 42.67 18.31 20 13067 4408 63471527
Drug hypersensitivity 41.67 18.31 7 13080 310680 63165255
Rheumatoid arthritis 40.84 18.31 3 13084 253816 63222119
Acute myeloid leukaemia 39.88 18.31 31 13056 17116 63458819
Deep vein thrombosis 39.84 18.31 66 13021 83734 63392201
Cerebral venous thrombosis 38.80 18.31 15 13072 2059 63473876
Cytogenetic analysis abnormal 37.97 18.31 12 13075 908 63475027
Aplastic anaemia 37.96 18.31 24 13063 9545 63466390
White blood cell count increased 37.31 18.31 48 13039 48513 63427422
Haemorrhage intracranial 37.31 18.31 27 13060 13392 63462543
Infusion related reaction 36.54 18.31 4 13083 245517 63230418
Myelodysplastic syndrome 36.19 18.31 29 13058 16725 63459210
Clonal evolution 35.12 18.31 7 13080 76 63475859
Bone marrow myelogram abnormal 33.70 18.31 6 13081 33 63475902
Liver disorder 33.55 18.31 48 13039 53639 63422296
Myalgia 33.27 18.31 85 13002 146444 63329491
Cytomegalovirus infection 32.49 18.31 30 13057 20922 63455013
Headache 31.20 18.31 230 12857 633011 62842924
Cerebral haemorrhage 29.50 18.31 34 13053 30695 63445240
Heavy menstrual bleeding 28.63 18.31 26 13061 17747 63458188
Marrow hyperplasia 28.37 18.31 9 13078 689 63475246
Blast cell count increased 27.82 18.31 8 13079 438 63475497
Drug intolerance 27.04 18.31 15 13072 308646 63167289
Glossodynia 26.39 18.31 3 13084 178873 63297062
Biopsy bone marrow abnormal 26.31 18.31 7 13080 287 63475648
Hepatic infection 26.04 18.31 8 13079 551 63475384
Blood bilirubin increased 25.88 18.31 35 13052 37105 63438830
Chronic lymphocytic leukaemia 25.78 18.31 12 13075 2602 63473333
Cerebral venous sinus thrombosis 25.69 18.31 11 13076 1961 63473974
Subdural haematoma 25.15 18.31 22 13065 14306 63461629
Swelling 24.68 18.31 13 13074 275365 63200570
Sepsis 24.21 18.31 78 13009 153045 63322890
Therapeutic response decreased 23.46 18.31 44 13043 61481 63414454
Superior sagittal sinus thrombosis 23.31 18.31 8 13079 783 63475152
Spleen operation 22.46 18.31 3 13084 0 63475935
Serum colour abnormal 22.46 18.31 3 13084 0 63475935
Cytogenetic abnormality 22.38 18.31 7 13080 512 63475423
Adenocarcinoma gastric 22.23 18.31 7 13080 523 63475412
Disease progression 21.69 18.31 65 13022 122693 63353242
Toxicity to various agents 21.67 18.31 12 13075 247238 63228697
Haematoma 21.55 18.31 31 13056 34789 63441146
Hepatic function abnormal 21.45 18.31 32 13055 37110 63438825
Megakaryocytes abnormal 21.06 18.31 4 13083 33 63475902
Purpura 21.03 18.31 18 13069 11367 63464568
Mesenteric vein thrombosis 20.67 18.31 8 13079 1102 63474833
Leukocytosis 20.49 18.31 26 13061 25909 63450026
Blast cell proliferation 20.38 18.31 3 13084 3 63475932
Abdominal discomfort 20.00 18.31 22 13065 320863 63155072
Hospice care 19.89 18.31 15 13072 7917 63468018
Haemorrhagic diathesis 19.87 18.31 12 13075 4403 63471532
Megakaryocytes increased 19.70 18.31 4 13083 48 63475887
Jaundice 19.52 18.31 27 13060 29224 63446711
Anaemia 19.49 18.31 115 12972 293315 63182620
Contusion 18.99 18.31 71 13016 149973 63325962
Joint swelling 18.78 18.31 24 13063 327642 63148293

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 808.75 18.49 466 9213 119251 34828001
Death 454.60 18.49 550 9129 397499 34549753
Platelet count abnormal 216.75 18.49 64 9615 2858 34944394
Platelet count increased 206.24 18.49 83 9596 9443 34937809
Product use in unapproved indication 170.29 18.49 185 9494 117314 34829938
Immune thrombocytopenia 145.39 18.49 64 9615 9088 34938164
Drug ineffective 116.14 18.49 331 9348 456420 34490832
Myelofibrosis 109.53 18.49 33 9646 1578 34945674
Therapy non-responder 91.00 18.49 80 9599 39066 34908186
Platelet disorder 70.57 18.49 24 9655 1697 34945555
Myelodysplastic syndrome 69.72 18.49 51 9628 19157 34928095
Acute myeloid leukaemia 62.92 18.49 47 9632 18223 34929029
Bone marrow reticulin fibrosis 59.98 18.49 13 9666 159 34947093
Petechiae 55.97 18.49 34 9645 9384 34937868
Epistaxis 52.01 18.49 72 9607 58179 34889073
Haematological malignancy 50.29 18.49 14 9665 504 34946748
Thrombocytopenia 49.12 18.49 123 9556 156124 34791128
Gingival bleeding 48.75 18.49 28 9651 6972 34940280
Disease progression 46.06 18.49 96 9583 107981 34839271
Liver disorder 44.21 18.49 50 9629 32947 34914305
Paroxysmal nocturnal haemoglobinuria 44.10 18.49 8 9671 35 34947217
Thrombocytosis 41.37 18.49 21 9658 4091 34943161
Clonal evolution 40.60 18.49 9 9670 123 34947129
Cytogenetic abnormality 38.74 18.49 13 9666 882 34946370
Haemorrhage 36.44 18.49 57 9622 51313 34895939
Contusion 32.51 18.49 45 9634 36319 34910933
Toxicity to various agents 32.10 18.49 8 9671 200354 34746898
Mucosal haemorrhage 27.86 18.49 12 9667 1613 34945639
Hypoparathyroidism 27.03 18.49 9 9670 596 34946656
Serum sickness 25.47 18.49 12 9667 1988 34945264
Chronic myelomonocytic leukaemia 22.49 18.49 8 9671 646 34946606
Blast cell count increased 21.96 18.49 9 9670 1069 34946183
Oral blood blister 21.58 18.49 3 9676 0 34947252
Acute myocardial infarction 20.86 18.49 46 9633 53673 34893579
Thrombosis 20.50 18.49 44 9635 50414 34896838
Mean platelet volume increased 20.20 18.49 7 9672 523 34946729
Hypotension 20.19 18.49 19 9660 221630 34725622
Drug interaction 19.85 18.49 20 9659 225926 34721326
Haemoglobin decreased 19.11 18.49 75 9604 120697 34826555

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 1375.67 16.48 720 16631 193944 79533093
Death 684.47 16.48 720 16631 565794 79161243
Platelet count increased 362.60 16.48 148 17203 22258 79704779
Platelet count abnormal 280.35 16.48 83 17268 4779 79722258
Product use in unapproved indication 278.43 16.48 306 17045 250053 79476984
Myelofibrosis 261.01 16.48 68 17283 2432 79724605
Petechiae 193.88 16.48 93 17258 20472 79706565
Immune thrombocytopenia 184.67 16.48 86 17265 17719 79709318
Thrombocytopenia 157.84 16.48 238 17113 265021 79462016
Haemorrhage 142.26 16.48 134 17217 90984 79636053
Thrombocytosis 140.17 16.48 57 17294 8469 79718568
Drug ineffective 126.14 16.48 515 16836 1080398 78646639
Therapy non-responder 113.09 16.48 119 17232 92186 79634851
Gingival bleeding 110.60 16.48 59 17292 16217 79710820
Bone marrow reticulin fibrosis 108.43 16.48 23 17328 327 79726710
Acute myeloid leukaemia 107.98 16.48 73 17278 30812 79696225
Myelodysplastic syndrome 102.08 16.48 70 17281 30231 79696806
Epistaxis 94.75 16.48 119 17232 111396 79615641
Transplant dysfunction 87.87 16.48 39 17312 7182 79719855
Haemoglobin decreased 80.23 16.48 160 17191 221959 79505078
Clonal evolution 76.20 16.48 16 17335 216 79726821
Mucosal haemorrhage 74.24 16.48 26 17325 2560 79724477
Platelet disorder 67.39 16.48 25 17326 2904 79724133
Cytogenetic abnormality 63.94 16.48 19 17332 1106 79725931
Pulmonary embolism 62.36 16.48 124 17227 171530 79555507
Disease progression 62.03 16.48 129 17222 184233 79542804
Paroxysmal nocturnal haemoglobinuria 61.84 16.48 14 17337 273 79726764
Liver disorder 53.25 16.48 72 17279 72345 79654692
Acute graft versus host disease 53.08 16.48 31 17320 10136 79716901
Cerebral infarction 52.56 16.48 57 17294 45619 79681418
Pain 50.95 16.48 47 17304 703755 79023282
Deep vein thrombosis 49.60 16.48 92 17259 120827 79606210
Concomitant disease aggravated 48.11 16.48 32 17319 13135 79713902
Cerebral haemorrhage 46.50 16.48 60 17291 57613 79669424
Mouth haemorrhage 46.00 16.48 29 17322 10870 79716167
Thrombosis 45.01 16.48 72 17279 84028 79643009
Toxicity to various agents 42.96 16.48 19 17332 421521 79305516
White blood cell count increased 42.86 16.48 66 17285 74567 79652470
Chronic lymphocytic leukaemia 42.81 16.48 21 17330 4845 79722192
Haematological malignancy 41.39 16.48 13 17338 912 79726125
Cerebral venous thrombosis 40.48 16.48 17 17334 2736 79724301
Contusion 38.69 16.48 94 17257 148682 79578355
Hospice care 37.50 16.48 25 17326 10299 79716738
Portal vein thrombosis 36.45 16.48 20 17331 5807 79721230
Haemorrhagic diathesis 35.64 16.48 20 17331 6064 79720973
Cytomegalovirus infection 35.37 16.48 45 17306 42599 79684438
Bone marrow myelogram abnormal 35.00 16.48 7 17344 73 79726964
Ecchymosis 33.01 16.48 27 17324 15179 79711858
Haemorrhage intracranial 32.45 16.48 34 17317 26159 79700878
Blood bilirubin increased 31.79 16.48 54 17297 66178 79660859
Mean platelet volume increased 31.15 16.48 11 17340 1109 79725928
Aplastic anaemia 31.14 16.48 28 17323 17877 79709160
Acute leukaemia 29.95 16.48 12 17339 1714 79725323
Sepsis 29.94 16.48 127 17224 269301 79457736
Serum sickness 29.82 16.48 15 17336 3651 79723386
Infusion related reaction 29.37 16.48 7 17344 230230 79496807
Antiphospholipid syndrome 28.89 16.48 12 17339 1879 79725158
Blast cell count increased 28.68 16.48 11 17340 1399 79725638
Hepatic infection 28.11 16.48 10 17341 1030 79726007
Joint swelling 27.86 16.48 14 17337 288632 79438405
Megakaryocytes abnormal 27.51 16.48 6 17345 98 79726939
Serum colour abnormal 27.50 16.48 4 17347 3 79727034
Chronic myeloid leukaemia 26.92 16.48 14 17337 3650 79723387
Splenectomy 26.74 16.48 9 17342 786 79726251
Cerebral venous sinus thrombosis 26.68 16.48 12 17339 2279 79724758
Drug hypersensitivity 26.67 16.48 16 17335 298900 79428137
Chronic graft versus host disease 26.04 16.48 17 17334 6764 79720273
Heavy menstrual bleeding 24.54 16.48 22 17329 13989 79713048
Superior sagittal sinus thrombosis 24.19 16.48 9 17342 1054 79725983
Therapy partial responder 24.12 16.48 24 17327 17373 79709664
Hypoparathyroidism 23.90 16.48 9 17342 1089 79725948
Musculoskeletal stiffness 22.96 16.48 5 17346 175003 79552034
Hypotension 22.76 16.48 38 17313 440279 79286758
Synovitis 22.65 16.48 3 17348 150731 79576306
Bone marrow failure 22.35 16.48 40 17311 51067 79675970
Chronic myelomonocytic leukaemia 22.18 16.48 8 17343 858 79726179
Biopsy bone marrow abnormal 22.08 16.48 7 17344 506 79726531
Dyspnoea 21.95 16.48 104 17247 856921 78870116
Concomitant disease progression 21.94 16.48 12 17339 3461 79723576
Hospitalisation 21.82 16.48 57 17294 94179 79632858
Acute myocardial infarction 21.44 16.48 50 17301 76986 79650051
Megakaryocytes increased 21.39 16.48 5 17346 113 79726924
Autoimmune haemolytic anaemia 20.58 16.48 16 17335 8364 79718673
Therapeutic response decreased 20.39 16.48 45 17306 66808 79660229
White blood cell count decreased 20.31 16.48 88 17263 188200 79538837
Transverse sinus thrombosis 20.30 16.48 7 17344 658 79726379
Neutrophil count decreased 19.91 16.48 55 17296 93904 79633133
Oral mucosa haematoma 19.19 16.48 4 17347 52 79726985
Evans syndrome 18.91 16.48 6 17345 435 79726602
Pneumonia 18.90 16.48 223 17128 660023 79067014
Infection 18.90 16.48 103 17248 241609 79485428
Pyrexia 18.89 16.48 228 17123 678481 79048556
Drug intolerance 18.62 16.48 18 17333 264101 79462936
Reticulocyte count increased 18.53 16.48 8 17343 1378 79725659
Haemosiderosis 17.86 16.48 6 17345 521 79726516
Febrile neutropenia 17.77 16.48 98 17253 230901 79496136
Reticulin increased 17.68 16.48 3 17348 11 79727026
Cytopenia 17.68 16.48 22 17329 20361 79706676
Myeloproliferative neoplasm 17.59 16.48 7 17344 982 79726055
Jaundice 17.52 16.48 37 17314 53312 79673725
Platelet glycoprotein gene mutation 17.47 16.48 3 17348 12 79727025
Asthma 17.44 16.48 4 17347 135091 79591946
Marrow hyperplasia 17.20 16.48 8 17343 1640 79725397
Transaminases increased 17.12 16.48 36 17315 51707 79675330
Mobility decreased 17.05 16.48 3 17348 122172 79604865
Subdural haematoma 16.93 16.48 27 17324 31407 79695630

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 | Suggest Off label Use Form| |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 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 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
ATP-binding cassette sub-family G member 2 Transporter IC50 5.51 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
26020 MMSL
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 0078-0684 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 0078-0685 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 0078-0686 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 0078-0687 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 0078-0697 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
PROMACTA HUMAN PRESCRIPTION DRUG LABEL 1 0078-0972 POWDER, FOR SUSPENSION 12.50 mg ORAL NDA 33 sections