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

Stem definitionDrug idCAS RN
tyrosine kinase inhibitors 4716 943319-70-8

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • ponatinib
  • iclusig
  • AP24534
  • ponatinib hydrochloride
  • ponatinib HCl
a pan-Bcr-Abl protein kinase Inhibitor
  • Molecular weight: 532.57
  • Formula: C29H27F3N6O
  • CLOGP: 6.11
  • LIPINSKI: 2
  • HAC: 7
  • HDO: 1
  • TPSA: 65.77
  • ALOGS: -5.26
  • ROTB: 7
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
45 mg O

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
Dec. 14, 2012 FDA ARIAD

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
Acute lymphocytic leukaemia recurrent 264.55 21.94 59 6855 2210 63479898
Philadelphia chromosome positive 192.06 21.94 34 6880 372 63481736
Cytogenetic analysis abnormal 181.93 21.94 37 6877 883 63481225
Chronic myeloid leukaemia recurrent 153.65 21.94 26 6888 213 63481895
Blast crisis in myelogenous leukaemia 119.64 21.94 24 6890 533 63481575
Drug resistance 114.67 21.94 54 6860 22879 63459229
Death 111.85 21.94 168 6746 374213 63107895
Dry skin 103.80 21.94 69 6845 56818 63425290
Neoplasm progression 93.77 21.94 55 6859 36373 63445735
Blast cell crisis 87.88 21.94 14 6900 75 63482033
Rash 76.66 21.94 180 6734 560691 62921417
Thrombocytopenia 71.34 21.94 85 6829 151072 63331036
Cytopenia 69.53 21.94 31 6883 11570 63470538
Peripheral arterial occlusive disease 67.60 21.94 23 6891 4178 63477930
Graft versus host disease 60.39 21.94 24 6890 6739 63475369
Therapeutic response delayed 59.81 21.94 14 6900 650 63481458
Stem cell transplant 54.46 21.94 16 6898 1806 63480302
Central nervous system leukaemia 48.26 21.94 9 6905 134 63481974
Platelet count decreased 47.80 21.94 61 6853 116061 63366047
Product dose omission issue 46.75 21.94 88 6826 234225 63247883
Pleural effusion 46.55 21.94 54 6860 93156 63388952
Ischaemic stroke 45.88 21.94 27 6887 17930 63464178
Hypertension 42.77 21.94 94 6820 279209 63202899
Catabolic state 41.40 21.94 7 6907 57 63482051
Leukaemia recurrent 41.09 21.94 12 6902 1326 63480782
Lipase increased 39.51 21.94 20 6894 9880 63472228
Ichthyosis acquired 38.28 21.94 5 6909 3 63482105
Chronic myeloid leukaemia transformation 36.55 21.94 7 6907 121 63481987
Pancreatitis 36.20 21.94 35 6879 49020 63433088
Off label use 35.46 21.94 156 6758 674306 62807802
Capillary leak syndrome 35.22 21.94 12 6902 2188 63479920
Skin exfoliation 34.17 21.94 32 6882 43070 63439038
Product administered to patient of inappropriate age 34.14 21.94 13 6901 3255 63478853
Pancytopenia 33.84 21.94 47 6867 96886 63385222
Pyrexia 32.85 21.94 119 6795 470359 63011749
Chemotherapy 30.81 21.94 10 6904 1569 63480539
Ichthyosis 27.97 21.94 5 6909 58 63482050
Bone pain 27.83 21.94 32 6882 54609 63427499
Cytokine release syndrome 27.62 21.94 18 6896 14296 63467812
Haematotoxicity 26.34 21.94 15 6899 9361 63472747
Soft tissue necrosis 25.94 21.94 7 6907 580 63481528
Peripheral artery stenosis 25.70 21.94 7 6907 601 63481507
Joint swelling 25.33 21.94 3 6911 327663 63154445
Philadelphia positive acute lymphocytic leukaemia 25.02 21.94 4 6910 22 63482086
Blood pressure increased 23.02 21.94 53 6861 162009 63320099
Constipation 22.07 21.94 64 6850 224879 63257229

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
Acute lymphocytic leukaemia recurrent 302.35 21.82 82 8715 2962 34945172
Drug resistance 193.81 21.82 105 8692 25822 34922312
Cytogenetic analysis abnormal 191.36 21.82 43 8754 696 34947438
Blast crisis in myelogenous leukaemia 183.15 21.82 40 8757 564 34947570
Neoplasm progression 164.81 21.82 91 8706 23209 34924925
Chronic myeloid leukaemia recurrent 136.00 21.82 26 8771 178 34947956
Philadelphia chromosome positive 125.79 21.82 27 8770 349 34947785
Death 101.59 21.82 272 8525 397777 34550357
Loss of therapeutic response 77.44 21.82 20 8777 594 34947540
Blast cell crisis 74.12 21.82 14 8783 89 34948045
Drug intolerance 70.89 21.82 81 8716 59489 34888645
Lipase increased 69.89 21.82 38 8759 9378 34938756
Autoimmune lymphoproliferative syndrome 61.68 21.82 13 8784 153 34947981
Gallbladder oedema 56.80 21.82 13 8784 229 34947905
Blast cells present 56.76 21.82 15 8782 488 34947646
Pancreatitis 53.35 21.82 57 8740 38834 34909300
Minimal residual disease 49.16 21.82 13 8784 424 34947710
Cytopenia 47.24 21.82 33 8764 12690 34935444
Pleural effusion 45.52 21.82 77 8720 81469 34866665
Chronic myeloid leukaemia transformation 45.07 21.82 10 8787 152 34947982
Periarthritis calcarea 44.79 21.82 9 8788 82 34948052
Articular calcification 44.50 21.82 9 8788 85 34948049
Peripheral arterial occlusive disease 44.40 21.82 24 8773 5850 34942284
Viral haemorrhagic cystitis 44.14 21.82 15 8782 1165 34946969
Thrombocytopenia 42.77 21.82 110 8687 156137 34791997
Hepatotoxicity 41.57 21.82 38 8759 21447 34926687
Immature granulocyte count increased 40.93 21.82 9 8788 131 34948003
Graft versus host disease 40.61 21.82 28 8769 10541 34937593
Loss of CAR T-cell persistence 39.76 21.82 7 8790 28 34948106
Adrenal cyst 39.56 21.82 9 8788 154 34947980
Central nervous system leukaemia 39.42 21.82 10 8787 276 34947858
Central nervous system neoplasm 39.05 21.82 8 8789 81 34948053
Haematopoietic stem cell mobilisation 39.03 21.82 9 8788 164 34947970
Stem cell transplant 38.82 21.82 16 8781 2123 34946011
Bone marrow transplant 37.70 21.82 13 8784 1055 34947079
Cytokine release syndrome 37.65 21.82 37 8760 22840 34925294
Platelet count decreased 36.65 21.82 88 8709 119629 34828505
Myopathy toxic 36.59 21.82 11 8786 575 34947559
Acute lymphocytic leukaemia 36.56 21.82 17 8780 3012 34945122
Clonal evolution 35.91 21.82 8 8789 124 34948010
Bone pain 35.06 21.82 34 8763 20652 34927482
Renal artery stenosis 34.66 21.82 15 8782 2246 34945888
Product dose omission issue 34.52 21.82 86 8711 119625 34828509
Gastrointestinal wall thickening 33.41 21.82 13 8784 1485 34946649
Red cell distribution width increased 32.83 21.82 20 8777 6103 34942031
Hepatic calcification 32.81 21.82 9 8788 338 34947796
Adrenomegaly 32.26 21.82 9 8788 360 34947774
Metamyelocyte count increased 31.86 21.82 9 8788 377 34947757
Renal artery stent placement 30.95 21.82 5 8792 10 34948124
Renal artery angioplasty 30.95 21.82 5 8792 10 34948124
Costal cartilage fracture 30.70 21.82 8 8789 246 34947888
Hypertension 30.27 21.82 89 8708 136354 34811780
Adrenal adenoma 29.78 21.82 9 8788 479 34947655
Dry skin 29.74 21.82 38 8759 31249 34916885
Activated partial thromboplastin time shortened 29.69 21.82 9 8788 484 34947650
Hospitalisation 29.46 21.82 52 8745 56850 34891284
Transplant 28.95 21.82 10 8787 816 34947318
Myelocyte count increased 27.79 21.82 8 8789 359 34947775
Graft versus host disease in gastrointestinal tract 27.70 21.82 15 8782 3668 34944466
Nephrocalcinosis 27.27 21.82 9 8788 639 34947495
Post transplant lymphoproliferative disorder 26.75 21.82 18 8779 6510 34941624
Activated partial thromboplastin time prolonged 26.46 21.82 20 8777 8675 34939459
Ichthyosis 26.25 21.82 6 8791 105 34948029
Diarrhoea 25.25 21.82 37 8760 389875 34558259
Bone neoplasm 25.19 21.82 7 8790 276 34947858
Pericardial effusion 25.10 21.82 31 8766 24631 34923503
Treatment failure 24.59 21.82 43 8754 46654 34901480
Epstein-Barr virus infection 24.22 21.82 18 8779 7610 34940524
Peripheral vascular disorder 23.35 21.82 15 8782 5021 34943113
Febrile neutropenia 22.84 21.82 81 8716 136768 34811366
Osteochondrosis 22.54 21.82 9 8788 1101 34947033
Leukaemia recurrent 22.44 21.82 10 8787 1605 34946529
Chronic myeloid leukaemia 22.33 21.82 11 8786 2213 34945921

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
Acute lymphocytic leukaemia recurrent 395.56 18.80 100 11925 4624 79727739
Philadelphia chromosome positive 234.40 18.80 46 11979 644 79731719
Blast crisis in myelogenous leukaemia 223.61 18.80 46 11979 827 79731536
Drug resistance 210.27 18.80 110 11915 42103 79690260
Cytogenetic analysis abnormal 165.75 18.80 38 11987 1152 79731211
Neoplasm progression 150.67 18.80 95 11930 51587 79680776
Chronic myeloid leukaemia recurrent 145.20 18.80 27 11998 278 79732085
Death 132.26 18.80 274 11751 566240 79166123
Lipase increased 93.78 18.80 47 11978 16419 79715944
Peripheral arterial occlusive disease 93.20 18.80 38 11987 8220 79724143
Thrombocytopenia 91.45 18.80 152 11873 265107 79467256
Platelet count decreased 90.25 18.80 128 11897 194536 79537827
Pleural effusion 86.52 18.80 108 11917 145154 79587209
Cytopenia 78.92 18.80 45 11980 20338 79712025
Dry skin 78.75 18.80 72 11953 67923 79664440
Blast cell crisis 75.66 18.80 14 12011 140 79732223
Stem cell transplant 70.62 18.80 25 12000 3679 79728684
Central nervous system leukaemia 66.87 18.80 15 12010 411 79731952
Autoimmune lymphoproliferative syndrome 66.63 18.80 13 12012 176 79732187
Graft versus host disease 63.12 18.80 35 11990 14991 79717372
Renal artery stenosis 60.72 18.80 22 12003 3460 79728903
Hypertension 57.80 18.80 143 11882 330849 79401514
Rash 53.74 18.80 200 11825 578158 79154205
Cytokine release syndrome 53.56 18.80 44 11981 35954 79696409
Ichthyosis 50.11 18.80 10 12015 153 79732210
Periarthritis calcarea 49.00 18.80 9 12016 86 79732277
Bone marrow transplant 48.67 18.80 15 12010 1433 79730930
Therapeutic response delayed 47.75 18.80 14 12011 1128 79731235
Product administered to patient of inappropriate age 47.52 18.80 21 12004 5532 79726831
Loss of therapeutic response 46.68 18.80 13 12012 871 79731492
Chronic myeloid leukaemia transformation 45.34 18.80 10 12015 253 79732110
Adrenal cyst 43.73 18.80 9 12016 162 79732201
Viral haemorrhagic cystitis 43.47 18.80 15 12010 2046 79730317
Neutrophil count decreased 42.31 18.80 61 11964 93898 79638465
Haematopoietic stem cell mobilisation 41.63 18.80 9 12016 207 79732156
Peripheral artery stenosis 41.62 18.80 13 12012 1298 79731065
Articular calcification 41.47 18.80 9 12016 211 79732152
Clonal evolution 40.99 18.80 9 12016 223 79732140
Adrenomegaly 40.90 18.80 10 12015 401 79731962
Pancreatitis 40.79 18.80 51 11974 68524 79663839
Loss of CAR T-cell persistence 37.15 18.80 6 12019 24 79732339
Pancytopenia 37.03 18.80 79 11946 165666 79566697
Acute lymphocytic leukaemia 36.83 18.80 17 12008 4952 79727411
Hepatic calcification 36.76 18.80 9 12016 363 79732000
Pneumonia fungal 36.16 18.80 22 12003 11188 79721175
Catabolic state 36.00 18.80 7 12018 93 79732270
Leukaemia recurrent 35.57 18.80 14 12011 2760 79729603
Febrile neutropenia 35.30 18.80 95 11930 230904 79501459
Central nervous system neoplasm 34.84 18.80 7 12018 111 79732252
Costal cartilage fracture 34.32 18.80 8 12017 261 79732102
Hepatic function abnormal 33.70 18.80 48 11977 73059 79659304
Ichthyosis acquired 33.51 18.80 5 12020 10 79732353
Hepatotoxicity 33.47 18.80 40 11985 51312 79681051
Activated partial thromboplastin time shortened 33.15 18.80 10 12015 889 79731474
Neutropenia 33.15 18.80 107 11918 287603 79444760
Blast cells present 32.74 18.80 10 12015 927 79731436
Ischaemic stroke 32.45 18.80 32 11993 33099 79699264
Immature granulocyte count increased 32.26 18.80 9 12016 607 79731756
Philadelphia positive acute lymphocytic leukaemia 31.98 18.80 6 12019 65 79732298
Metamyelocyte count increased 31.92 18.80 9 12016 631 79731732
Off label use 31.59 18.80 239 11786 906976 78825387
Pyrexia 31.48 18.80 192 11833 678517 79053846
Skin exfoliation 31.21 18.80 40 11985 55060 79677303
Amylase increased 31.12 18.80 20 12005 11189 79721174
Renal artery angioplasty 30.57 18.80 5 12020 22 79732341
Minimal residual disease 29.28 18.80 8 12017 499 79731864
Activated partial thromboplastin time prolonged 29.06 18.80 21 12004 14207 79718156
Chronic graft versus host disease 29.04 18.80 16 12009 6765 79725598
Cerebral infarction 28.82 18.80 35 11990 45641 79686722
Bone pain 27.77 18.80 38 11987 55704 79676659
Red cell distribution width increased 27.77 18.80 21 12004 15221 79717142
Joint swelling 27.77 18.80 5 12020 288641 79443722
Carotid artery stenosis 27.77 18.80 17 12008 8741 79723622
Capillary leak syndrome 27.76 18.80 13 12012 3912 79728451
Myopathy toxic 27.13 18.80 9 12016 1089 79731274
Drug hypersensitivity 27.04 18.80 6 12019 298910 79433453
Myelocyte count increased 25.99 18.80 8 12017 761 79731602
Adrenal adenoma 25.87 18.80 9 12016 1258 79731105
Chronic myeloid leukaemia 25.50 18.80 12 12013 3652 79728711
Renal artery stent placement 25.47 18.80 5 12020 70 79732293
Fall 25.10 18.80 22 12003 487607 79244756
Coronary artery stenosis 24.53 18.80 18 12007 12466 79719897
Moyamoya disease 24.51 18.80 5 12020 86 79732277
Epstein-Barr virus infection 24.38 18.80 19 12006 14397 79717966
Nephrocalcinosis 24.37 18.80 9 12016 1493 79730870
Peripheral vascular disorder 23.97 18.80 15 12010 8015 79724348
Pericardial effusion 23.76 18.80 32 11993 46205 79686158
Post transplant lymphoproliferative disorder 23.60 18.80 17 12008 11447 79720916
Pityriasis rubra pilaris 23.13 18.80 5 12020 115 79732248
Diaphragmatic disorder 23.03 18.80 9 12016 1741 79730622
Liver disorder 22.89 18.80 40 11985 72377 79659986
Malignant neoplasm progression 22.87 18.80 58 11967 135932 79596431
Full blood count decreased 22.80 18.80 24 12001 26795 79705568
Carotid arteriosclerosis 22.58 18.80 10 12015 2646 79729717
Osteochondrosis 21.89 18.80 9 12016 1987 79730376
White blood cell count decreased 21.63 18.80 70 11955 188218 79544145
Procalcitonin increased 21.40 18.80 10 12015 2996 79729367
Blast cell count increased 21.24 18.80 8 12017 1402 79730961
Neoplasm recurrence 21.00 18.80 11 12014 4203 79728160
Angina pectoris 20.99 18.80 32 11993 51700 79680663
Soft tissue necrosis 20.63 18.80 7 12018 908 79731455
Vascular occlusion 20.62 18.80 8 12017 1518 79730845
Abdominal pain 20.45 18.80 114 11911 389455 79342908
Leukaemia 20.07 18.80 12 12013 5913 79726450
Transplant 19.96 18.80 7 12018 1001 79731362
Constipation 19.92 18.80 90 11935 282960 79449403
Graft versus host disease in skin 19.80 18.80 12 12013 6061 79726302
Haemangioma 19.78 18.80 9 12016 2536 79729827
Vomiting 19.42 18.80 45 11980 665783 79066580
Mesenteric arterial occlusion 19.42 18.80 5 12020 248 79732115
Gene mutation 19.32 18.80 9 12016 2677 79729686
Graft versus host disease in gastrointestinal tract 19.29 18.80 12 12013 6344 79726019
Full blood count abnormal 19.27 18.80 27 11998 40447 79691916
Blood bilirubin increased 18.90 18.80 35 11990 66197 79666166

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L01EA05 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
PROTEIN KINASE INHIBITORS
BCR-ABL tyrosine kinase inhibitors
FDA MoA N0000175076 Protein Kinase Inhibitors
MeSH PA D000970 Antineoplastic Agents
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D047428 Protein Kinase Inhibitors
FDA EPC N0000175605 Kinase Inhibitor
CHEBI has role CHEBI:35610 antineoplastic agents
CHEBI has role CHEBI:38637 tyrosine kinase inhibitors

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

DiseaseRelationSNOMED_IDDOID
Chronic myeloid leukemia indication 92818009 DOID:8552
Philadelphia chromosome-positive acute lymphoblastic leukemia indication 425688002




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 11.98 acidic
pKa2 8.49 Basic
pKa3 5.58 Basic
pKa4 4.36 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 10MG BASE ICLUSIG TAKEDA PHARMS USA N203469 Dec. 18, 2020 RX TABLET ORAL 9029533 Dec. 22, 2026 A METHOD FOR THE TREATMENT OF LEUKEMIAS
EQ 10MG BASE ICLUSIG TAKEDA PHARMS USA N203469 Dec. 18, 2020 RX TABLET ORAL 9029533 Dec. 22, 2026 A METHOD FOR TREATING ACUTE LYMPHOBLASTIC LEUKEMIA
EQ 10MG BASE ICLUSIG TAKEDA PHARMS USA N203469 Dec. 18, 2020 RX TABLET ORAL 9029533 Dec. 22, 2026 A METHOD FOR TREATING LEUKEMIA RESULTING FROM A MUTATION IN THE BCR-ABL KINASE DOMAIN
EQ 10MG BASE ICLUSIG TAKEDA PHARMS USA N203469 Dec. 18, 2020 RX TABLET ORAL 9029533 Dec. 22, 2026 A METHOD FOR TREATING PHILADELPHIA CHROMOSOME POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA
EQ 10MG BASE ICLUSIG TAKEDA PHARMS USA N203469 Dec. 18, 2020 RX TABLET ORAL 9029533 Dec. 22, 2026 A METHOD OF TREATING CHRONIC MYELOGENOUS LEUKEMIA
EQ 15MG BASE ICLUSIG TAKEDA PHARMS USA N203469 Dec. 14, 2012 RX TABLET ORAL 9029533 Dec. 22, 2026 A METHOD FOR THE TREATMENT OF LEUKEMIAS
EQ 15MG BASE ICLUSIG TAKEDA PHARMS USA N203469 Dec. 14, 2012 RX TABLET ORAL 9029533 Dec. 22, 2026 A METHOD FOR TREATING ACUTE LYMPHOBLASTIC LEUKEMIA
EQ 15MG BASE ICLUSIG TAKEDA PHARMS USA N203469 Dec. 14, 2012 RX TABLET ORAL 9029533 Dec. 22, 2026 A METHOD FOR TREATING LEUKEMIA RESULTING FROM A MUTATION IN THE BCR-ABL KINASE DOMAIN
EQ 15MG BASE ICLUSIG TAKEDA PHARMS USA N203469 Dec. 14, 2012 RX TABLET ORAL 9029533 Dec. 22, 2026 A METHOD FOR TREATING PHILADELPHIA CHROMOSOME POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA
EQ 15MG BASE ICLUSIG TAKEDA PHARMS USA N203469 Dec. 14, 2012 RX TABLET ORAL 9029533 Dec. 22, 2026 A METHOD OF TREATING CHRONIC MYELOGENOUS LEUKEMIA
EQ 30MG BASE ICLUSIG TAKEDA PHARMS USA N203469 April 23, 2015 RX TABLET ORAL 9029533 Dec. 22, 2026 A METHOD FOR THE TREATMENT OF LEUKEMIAS
EQ 30MG BASE ICLUSIG TAKEDA PHARMS USA N203469 April 23, 2015 RX TABLET ORAL 9029533 Dec. 22, 2026 A METHOD FOR TREATING ACUTE LYMPHOBLASTIC LEUKEMIA
EQ 30MG BASE ICLUSIG TAKEDA PHARMS USA N203469 April 23, 2015 RX TABLET ORAL 9029533 Dec. 22, 2026 A METHOD FOR TREATING LEUKEMIA RESULTING FROM A MUTATION IN THE BCR-ABL KINASE DOMAIN
EQ 30MG BASE ICLUSIG TAKEDA PHARMS USA N203469 April 23, 2015 RX TABLET ORAL 9029533 Dec. 22, 2026 A METHOD FOR TREATING PHILADELPHIA CHROMOSOME POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA
EQ 30MG BASE ICLUSIG TAKEDA PHARMS USA N203469 April 23, 2015 RX TABLET ORAL 9029533 Dec. 22, 2026 A METHOD OF TREATING CHRONIC MYELOGENOUS LEUKEMIA
EQ 45MG BASE ICLUSIG TAKEDA PHARMS USA N203469 Dec. 14, 2012 RX TABLET ORAL 9029533 Dec. 22, 2026 A METHOD FOR THE TREATMENT OF LEUKEMIAS
EQ 45MG BASE ICLUSIG TAKEDA PHARMS USA N203469 Dec. 14, 2012 RX TABLET ORAL 9029533 Dec. 22, 2026 A METHOD FOR TREATING ACUTE LYMPHOBLASTIC LEUKEMIA
EQ 45MG BASE ICLUSIG TAKEDA PHARMS USA N203469 Dec. 14, 2012 RX TABLET ORAL 9029533 Dec. 22, 2026 A METHOD FOR TREATING LEUKEMIA RESULTING FROM A MUTATION IN THE BCR-ABL KINASE DOMAIN
EQ 45MG BASE ICLUSIG TAKEDA PHARMS USA N203469 Dec. 14, 2012 RX TABLET ORAL 9029533 Dec. 22, 2026 A METHOD FOR TREATING PHILADELPHIA CHROMOSOME POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA
EQ 45MG BASE ICLUSIG TAKEDA PHARMS USA N203469 Dec. 14, 2012 RX TABLET ORAL 9029533 Dec. 22, 2026 A METHOD OF TREATING CHRONIC MYELOGENOUS LEUKEMIA
EQ 10MG BASE ICLUSIG TAKEDA PHARMS USA N203469 Dec. 18, 2020 RX TABLET ORAL 11192895 Dec. 12, 2033 A METHOD FOR TREATING CHRONIC MYELOID LEUKEMIA
EQ 10MG BASE ICLUSIG TAKEDA PHARMS USA N203469 Dec. 18, 2020 RX TABLET ORAL 11192895 Dec. 12, 2033 A METHOD FOR TREATING LEUKEMIA RESULTING FROM A MUTATION IN THE BCR-ABL KINASE DOMAIN
EQ 10MG BASE ICLUSIG TAKEDA PHARMS USA N203469 Dec. 18, 2020 RX TABLET ORAL 11192895 Dec. 12, 2033 A METHOD FOR TREATING PHILADELPHIA CHROMOSOME POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA
EQ 10MG BASE ICLUSIG TAKEDA PHARMS USA N203469 Dec. 18, 2020 RX TABLET ORAL 11192897 Dec. 12, 2033 A METHOD FOR TREATING CHRONIC MYELOID LEUKEMIA
EQ 10MG BASE ICLUSIG TAKEDA PHARMS USA N203469 Dec. 18, 2020 RX TABLET ORAL 11192897 Dec. 12, 2033 A METHOD FOR TREATING LEUKEMIA RESULTING FROM A MUTATION IN THE BCR-ABL KINASE DOMAIN
EQ 10MG BASE ICLUSIG TAKEDA PHARMS USA N203469 Dec. 18, 2020 RX TABLET ORAL 11192897 Dec. 12, 2033 A METHOD FOR TREATING PHILADELPHIA CHROMOSOME POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA
EQ 10MG BASE ICLUSIG TAKEDA PHARMS USA N203469 Dec. 18, 2020 RX TABLET ORAL 11384086 Dec. 12, 2033 A METHOD FOR TREATING CHRONIC MYELOID LEUKEMIA
EQ 10MG BASE ICLUSIG TAKEDA PHARMS USA N203469 Dec. 18, 2020 RX TABLET ORAL 11384086 Dec. 12, 2033 A METHOD FOR TREATING LEUKEMIA RESULTING FROM A MUTATION IN THE BCR-ABL KINASE DOMAIN
EQ 10MG BASE ICLUSIG TAKEDA PHARMS USA N203469 Dec. 18, 2020 RX TABLET ORAL 11384086 Dec. 12, 2033 A METHOD FOR TREATING PHILADELPHIA CHROMOSOME POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA
EQ 10MG BASE ICLUSIG TAKEDA PHARMS USA N203469 Dec. 18, 2020 RX TABLET ORAL 9493470 Dec. 12, 2033 A METHOD FOR TREATING CHRONIC MYELOID LEUKEMIA
EQ 10MG BASE ICLUSIG TAKEDA PHARMS USA N203469 Dec. 18, 2020 RX TABLET ORAL 9493470 Dec. 12, 2033 A METHOD FOR TREATING PHILADELPHIA CHROMOSOME POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA
EQ 15MG BASE ICLUSIG TAKEDA PHARMS USA N203469 Dec. 14, 2012 RX TABLET ORAL 11192895 Dec. 12, 2033 A METHOD FOR TREATING CHRONIC MYELOID LEUKEMIA
EQ 15MG BASE ICLUSIG TAKEDA PHARMS USA N203469 Dec. 14, 2012 RX TABLET ORAL 11192895 Dec. 12, 2033 A METHOD FOR TREATING LEUKEMIA RESULTING FROM A MUTATION IN THE BCR-ABL KINASE DOMAIN
EQ 15MG BASE ICLUSIG TAKEDA PHARMS USA N203469 Dec. 14, 2012 RX TABLET ORAL 11192895 Dec. 12, 2033 A METHOD FOR TREATING PHILADELPHIA CHROMOSOME POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA
EQ 15MG BASE ICLUSIG TAKEDA PHARMS USA N203469 Dec. 14, 2012 RX TABLET ORAL 11192897 Dec. 12, 2033 A METHOD FOR TREATING CHRONIC MYELOID LEUKEMIA
EQ 15MG BASE ICLUSIG TAKEDA PHARMS USA N203469 Dec. 14, 2012 RX TABLET ORAL 11192897 Dec. 12, 2033 A METHOD FOR TREATING LEUKEMIA RESULTING FROM A MUTATION IN THE BCR-ABL KINASE DOMAIN
EQ 15MG BASE ICLUSIG TAKEDA PHARMS USA N203469 Dec. 14, 2012 RX TABLET ORAL 11192897 Dec. 12, 2033 A METHOD FOR TREATING PHILADELPHIA CHROMOSOME POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA
EQ 15MG BASE ICLUSIG TAKEDA PHARMS USA N203469 Dec. 14, 2012 RX TABLET ORAL 11384086 Dec. 12, 2033 A METHOD FOR TREATING CHRONIC MYELOID LEUKEMIA
EQ 15MG BASE ICLUSIG TAKEDA PHARMS USA N203469 Dec. 14, 2012 RX TABLET ORAL 11384086 Dec. 12, 2033 A METHOD FOR TREATING LEUKEMIA RESULTING FROM A MUTATION IN THE BCR-ABL KINASE DOMAIN
EQ 15MG BASE ICLUSIG TAKEDA PHARMS USA N203469 Dec. 14, 2012 RX TABLET ORAL 11384086 Dec. 12, 2033 A METHOD FOR TREATING PHILADELPHIA CHROMOSOME POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA
EQ 15MG BASE ICLUSIG TAKEDA PHARMS USA N203469 Dec. 14, 2012 RX TABLET ORAL 9493470 Dec. 12, 2033 A METHOD FOR TREATING CHRONIC MYELOID LEUKEMIA
EQ 15MG BASE ICLUSIG TAKEDA PHARMS USA N203469 Dec. 14, 2012 RX TABLET ORAL 9493470 Dec. 12, 2033 A METHOD FOR TREATING PHILADELPHIA CHROMOSOME POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA
EQ 30MG BASE ICLUSIG TAKEDA PHARMS USA N203469 April 23, 2015 RX TABLET ORAL 11192895 Dec. 12, 2033 A METHOD FOR TREATING CHRONIC MYELOID LEUKEMIA
EQ 30MG BASE ICLUSIG TAKEDA PHARMS USA N203469 April 23, 2015 RX TABLET ORAL 11192895 Dec. 12, 2033 A METHOD FOR TREATING LEUKEMIA RESULTING FROM A MUTATION IN THE BCR-ABL KINASE DOMAIN
EQ 30MG BASE ICLUSIG TAKEDA PHARMS USA N203469 April 23, 2015 RX TABLET ORAL 11192895 Dec. 12, 2033 A METHOD FOR TREATING PHILADELPHIA CHROMOSOME POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA
EQ 30MG BASE ICLUSIG TAKEDA PHARMS USA N203469 April 23, 2015 RX TABLET ORAL 11192897 Dec. 12, 2033 A METHOD FOR TREATING CHRONIC MYELOID LEUKEMIA
EQ 30MG BASE ICLUSIG TAKEDA PHARMS USA N203469 April 23, 2015 RX TABLET ORAL 11192897 Dec. 12, 2033 A METHOD FOR TREATING LEUKEMIA RESULTING FROM A MUTATION IN THE BCR-ABL KINASE DOMAIN
EQ 30MG BASE ICLUSIG TAKEDA PHARMS USA N203469 April 23, 2015 RX TABLET ORAL 11192897 Dec. 12, 2033 A METHOD FOR TREATING PHILADELPHIA CHROMOSOME POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA
EQ 30MG BASE ICLUSIG TAKEDA PHARMS USA N203469 April 23, 2015 RX TABLET ORAL 11384086 Dec. 12, 2033 A METHOD FOR TREATING CHRONIC MYELOID LEUKEMIA
EQ 30MG BASE ICLUSIG TAKEDA PHARMS USA N203469 April 23, 2015 RX TABLET ORAL 11384086 Dec. 12, 2033 A METHOD FOR TREATING LEUKEMIA RESULTING FROM A MUTATION IN THE BCR-ABL KINASE DOMAIN
EQ 30MG BASE ICLUSIG TAKEDA PHARMS USA N203469 April 23, 2015 RX TABLET ORAL 11384086 Dec. 12, 2033 A METHOD FOR TREATING PHILADELPHIA CHROMOSOME POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA
EQ 30MG BASE ICLUSIG TAKEDA PHARMS USA N203469 April 23, 2015 RX TABLET ORAL 9493470 Dec. 12, 2033 A METHOD FOR TREATING CHRONIC MYELOID LEUKEMIA
EQ 30MG BASE ICLUSIG TAKEDA PHARMS USA N203469 April 23, 2015 RX TABLET ORAL 9493470 Dec. 12, 2033 A METHOD FOR TREATING PHILADELPHIA CHROMOSOME POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA
EQ 45MG BASE ICLUSIG TAKEDA PHARMS USA N203469 Dec. 14, 2012 RX TABLET ORAL 11192895 Dec. 12, 2033 A METHOD FOR TREATING CHRONIC MYELOID LEUKEMIA
EQ 45MG BASE ICLUSIG TAKEDA PHARMS USA N203469 Dec. 14, 2012 RX TABLET ORAL 11192895 Dec. 12, 2033 A METHOD FOR TREATING LEUKEMIA RESULTING FROM A MUTATION IN THE BCR-ABL KINASE DOMAIN
EQ 45MG BASE ICLUSIG TAKEDA PHARMS USA N203469 Dec. 14, 2012 RX TABLET ORAL 11192895 Dec. 12, 2033 A METHOD FOR TREATING PHILADELPHIA CHROMOSOME POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA
EQ 45MG BASE ICLUSIG TAKEDA PHARMS USA N203469 Dec. 14, 2012 RX TABLET ORAL 11192897 Dec. 12, 2033 A METHOD FOR TREATING CHRONIC MYELOID LEUKEMIA
EQ 45MG BASE ICLUSIG TAKEDA PHARMS USA N203469 Dec. 14, 2012 RX TABLET ORAL 11192897 Dec. 12, 2033 A METHOD FOR TREATING LEUKEMIA RESULTING FROM A MUTATION IN THE BCR-ABL KINASE DOMAIN
EQ 45MG BASE ICLUSIG TAKEDA PHARMS USA N203469 Dec. 14, 2012 RX TABLET ORAL 11192897 Dec. 12, 2033 A METHOD FOR TREATING PHILADELPHIA CHROMOSOME POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA
EQ 45MG BASE ICLUSIG TAKEDA PHARMS USA N203469 Dec. 14, 2012 RX TABLET ORAL 11384086 Dec. 12, 2033 A METHOD FOR TREATING CHRONIC MYELOID LEUKEMIA
EQ 45MG BASE ICLUSIG TAKEDA PHARMS USA N203469 Dec. 14, 2012 RX TABLET ORAL 11384086 Dec. 12, 2033 A METHOD FOR TREATING LEUKEMIA RESULTING FROM A MUTATION IN THE BCR-ABL KINASE DOMAIN
EQ 45MG BASE ICLUSIG TAKEDA PHARMS USA N203469 Dec. 14, 2012 RX TABLET ORAL 11384086 Dec. 12, 2033 A METHOD FOR TREATING PHILADELPHIA CHROMOSOME POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA
EQ 45MG BASE ICLUSIG TAKEDA PHARMS USA N203469 Dec. 14, 2012 RX TABLET ORAL 9493470 Dec. 12, 2033 A METHOD FOR TREATING CHRONIC MYELOID LEUKEMIA
EQ 45MG BASE ICLUSIG TAKEDA PHARMS USA N203469 Dec. 14, 2012 RX TABLET ORAL 9493470 Dec. 12, 2033 A METHOD FOR TREATING PHILADELPHIA CHROMOSOME POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
EQ 10MG BASE ICLUSIG TAKEDA PHARMS USA N203469 Dec. 18, 2020 RX TABLET ORAL Dec. 18, 2023 CHRONIC PHASE (CP) CHRONIC MYELOID LEUKEMIA (CML) WITH RESISTANCE OR INTOLERANCE TO AT LEAST TWO PRIOR KINASE INHIBITORS
EQ 15MG BASE ICLUSIG TAKEDA PHARMS USA N203469 Dec. 14, 2012 RX TABLET ORAL Dec. 18, 2023 CHRONIC PHASE (CP) CHRONIC MYELOID LEUKEMIA (CML) WITH RESISTANCE OR INTOLERANCE TO AT LEAST TWO PRIOR KINASE INHIBITORS
EQ 30MG BASE ICLUSIG TAKEDA PHARMS USA N203469 April 23, 2015 RX TABLET ORAL Dec. 18, 2023 CHRONIC PHASE (CP) CHRONIC MYELOID LEUKEMIA (CML) WITH RESISTANCE OR INTOLERANCE TO AT LEAST TWO PRIOR KINASE INHIBITORS
EQ 45MG BASE ICLUSIG TAKEDA PHARMS USA N203469 Dec. 14, 2012 RX TABLET ORAL Dec. 18, 2023 CHRONIC PHASE (CP) CHRONIC MYELOID LEUKEMIA (CML) WITH RESISTANCE OR INTOLERANCE TO AT LEAST TWO PRIOR KINASE INHIBITORS

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Breakpoint cluster region protein Kinase INHIBITOR Kd 7.30 CHEMBL CHEMBL
Tyrosine-protein kinase ABL1 Kinase INHIBITOR IC50 9.43 WOMBAT-PK CHEMBL
Platelet-derived growth factor receptor beta Kinase IC50 8.92 CHEMBL
Mast/stem cell growth factor receptor Kit Kinase INHIBITOR IC50 7.90 WOMBAT-PK
Proto-oncogene tyrosine-protein kinase Src Kinase IC50 8.52 CHEMBL
Tyrosine-protein kinase Lck Kinase Kd 7.62 CHEMBL
Tyrosine-protein kinase Yes Kinase Kd 6.66 CHEMBL
Tyrosine-protein kinase Fyn Kinase Kd 7.44 CHEMBL
Ephrin type-A receptor 2 Kinase Kd 7.57 CHEMBL
Serine/threonine-protein kinase B-raf Kinase Kd 5.92 CHEMBL
Receptor-type tyrosine-protein kinase FLT3 Kinase IC50 9.52 CHEMBL
Proto-oncogene tyrosine-protein kinase receptor Ret Kinase IC50 7.59 CHEMBL
Vascular endothelial growth factor receptor 1 Kinase IC50 8.43 CHEMBL
Vascular endothelial growth factor receptor 2 Kinase INHIBITOR IC50 8.82 WOMBAT-PK
Macrophage colony-stimulating factor 1 receptor Kinase IC50 8.07 CHEMBL
Platelet-derived growth factor receptor alpha Kinase INHIBITOR IC50 8.96 WOMBAT-PK
Myosin light chain kinase, smooth muscle Kinase Kd 7 CHEMBL
Fibroblast growth factor receptor 3 Kinase IC50 8.03 CHEMBL
Tyrosine-protein kinase HCK Kinase Kd 7.09 CHEMBL
Tyrosine-protein kinase JAK1 Kinase IC50 7.49 CHEMBL
High affinity nerve growth factor receptor Kinase IC50 7.94 CHEMBL
Tyrosine-protein kinase JAK2 Kinase IC50 6.77 CHEMBL
Tyrosine-protein kinase CSK Kinase INHIBITOR IC50 8.27 WOMBAT-PK
Tyrosine-protein kinase Lyn Kinase INHIBITOR IC50 9.62 WOMBAT-PK
Fibroblast growth factor receptor 1 Kinase INHIBITOR IC50 8.66 WOMBAT-PK
Abelson tyrosine-protein kinase 2 Kinase Kd 7.70 CHEMBL
Mitogen-activated protein kinase 11 Kinase Kd 6 CHEMBL
Ephrin type-A receptor 5 Kinase Kd 8.10 CHEMBL
Ephrin type-A receptor 4 Kinase Kd 4.77 CHEMBL
Fibroblast growth factor receptor 2 Kinase IC50 8.89 CHEMBL
TRAF2 and NCK-interacting protein kinase Kinase Kd 6.42 CHEMBL
Tyrosine-protein kinase Fgr Kinase Kd 7.42 CHEMBL
Mitogen-activated protein kinase 14 Kinase Kd 6.81 CHEMBL
Tyrosine-protein kinase FRK Kinase Kd 7.03 CHEMBL
Cyclin-G-associated kinase Kinase Kd 5.73 CHEMBL
Receptor-interacting serine/threonine-protein kinase 2 Kinase IC50 8.17 CHEMBL
Cyclin-dependent kinase 16 Kinase Kd 5.76 CHEMBL
Mitogen-activated protein kinase 9 Kinase Kd 5.10 CHEMBL
Calcium/calmodulin-dependent protein kinase kinase 2 Kinase Kd 5.75 CHEMBL
Epithelial discoidin domain-containing receptor 1 Kinase Kd 7.75 CHEMBL
Ephrin type-B receptor 4 Kinase Kd 5.83 CHEMBL
TGF-beta receptor type-2 Kinase Kd 5.75 CHEMBL
MAP kinase-activated protein kinase 2 Kinase Kd 6.33 CHEMBL
Tyrosine-protein kinase BTK Kinase Kd 5.74 CHEMBL
Ephrin type-B receptor 2 Kinase Kd 5.73 CHEMBL
Non-receptor tyrosine-protein kinase TNK1 Kinase Kd 7.08 CHEMBL
Cyclin-dependent kinase 17 Kinase Kd 6.47 CHEMBL
Mitogen-activated protein kinase kinase kinase MLT Kinase Kd 7.39 CHEMBL
Protein-tyrosine kinase 2-beta Kinase Kd 6.53 CHEMBL
Maternal embryonic leucine zipper kinase Kinase Kd 5.53 CHEMBL
Discoidin domain-containing receptor 2 Kinase Kd 7.06 CHEMBL
Mitogen-activated protein kinase kinase kinase kinase 1 Kinase Kd 6.11 CHEMBL
cAMP-dependent protein kinase catalytic subunit alpha Kinase IC50 6.21 CHEMBL
Mitogen-activated protein kinase kinase kinase kinase 4 Kinase Kd 6.51 CHEMBL
Cyclin-dependent kinase 19 Kinase INHIBITOR Kd 7.92 IUPHAR
Cyclin-dependent kinase 8 Kinase INHIBITOR Kd 8.17 IUPHAR
Ephrin type-A receptor 1 Kinase Kd 5.94 CHEMBL
Ephrin type-B receptor 3 Kinase Kd 6.26 CHEMBL
Receptor-interacting serine/threonine-protein kinase 1 Kinase INHIBITOR IC50 7.92 IUPHAR
Fibroblast growth factor receptor 4 Kinase IC50 8.15 CHEMBL
Mitogen-activated protein kinase kinase kinase kinase 2 Kinase Kd 7.39 CHEMBL
Interleukin-1 receptor-associated kinase 4 Kinase Kd 5.66 CHEMBL
Interleukin-1 receptor-associated kinase 1 Kinase Kd 6.16 CHEMBL
Serine/threonine-protein kinase TAO3 Kinase Kd 5.67 CHEMBL
Serine/threonine-protein kinase ULK3 Kinase Kd 5.76 CHEMBL
Mitogen-activated protein kinase kinase kinase 1 Kinase Kd 6.31 CHEMBL
Dual specificity mitogen-activated protein kinase kinase 5 Kinase Kd 5.53 CHEMBL
Bcr/Abl fusion protein Kinase IC50 9.30 CHEMBL
Receptor-interacting serine/threonine-protein kinase 3 Kinase INHIBITOR Ki 8.80 IUPHAR
Potassium voltage-gated channel subfamily H member 2 Ion channel IC50 6.11 CHEMBL
ATP-dependent RNA helicase DDX1 Enzyme Kd 7.07 CHEMBL
ATP-binding cassette sub-family G member 2 Transporter IC50 7.40 CHEMBL
Proto-oncogene tyrosine-protein kinase Src Kinase IC50 9.05 CHEMBL

External reference:

IDSource
4340891KFS UNII
D09950 KEGG_DRUG
4032031 VUID
N0000186141 NUI
1114544-31-8 SECONDARY_CAS_RN
4032031 VANDF
C2987417 UMLSCUI
CHEBI:78543 CHEBI
0LI PDB_CHEM_ID
CHEMBL1171837 ChEMBL_ID
24826799 PUBCHEM_CID
DB08901 DRUGBANK_ID
9362 INN_ID
C545373 MESH_SUPPLEMENTAL_RECORD_UI
5890 IUPHAR_LIGAND_ID
1364347 RXNORM
196462 MMSL
29016 MMSL
31534 MMSL
d07936 MMSL
014797 NDDF
014798 NDDF
703796003 SNOMEDCT_US
703797007 SNOMEDCT_US
703798002 SNOMEDCT_US
CHEMBL2105708 ChEMBL_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Iclusig HUMAN PRESCRIPTION DRUG LABEL 1 63020-533 TABLET, FILM COATED 30 mg ORAL NDA 33 sections
Iclusig HUMAN PRESCRIPTION DRUG LABEL 1 63020-533 TABLET, FILM COATED 30 mg ORAL NDA 33 sections
Iclusig HUMAN PRESCRIPTION DRUG LABEL 1 63020-533 TABLET, FILM COATED 30 mg ORAL NDA 33 sections
Iclusig HUMAN PRESCRIPTION DRUG LABEL 1 63020-534 TABLET, FILM COATED 45 mg ORAL NDA 33 sections
Iclusig HUMAN PRESCRIPTION DRUG LABEL 1 63020-534 TABLET, FILM COATED 45 mg ORAL NDA 33 sections
Iclusig HUMAN PRESCRIPTION DRUG LABEL 1 63020-534 TABLET, FILM COATED 45 mg ORAL NDA 33 sections
Iclusig HUMAN PRESCRIPTION DRUG LABEL 1 63020-535 TABLET, FILM COATED 15 mg ORAL NDA 33 sections
Iclusig HUMAN PRESCRIPTION DRUG LABEL 1 63020-535 TABLET, FILM COATED 15 mg ORAL NDA 33 sections
Iclusig HUMAN PRESCRIPTION DRUG LABEL 1 63020-535 TABLET, FILM COATED 15 mg ORAL NDA 33 sections
Iclusig HUMAN PRESCRIPTION DRUG LABEL 1 63020-536 TABLET, FILM COATED 10 mg ORAL NDA 33 sections
Iclusig HUMAN PRESCRIPTION DRUG LABEL 1 63020-536 TABLET, FILM COATED 10 mg ORAL NDA 33 sections
Iclusig HUMAN PRESCRIPTION DRUG LABEL 1 63020-536 TABLET, FILM COATED 10 mg ORAL NDA 33 sections