talazoparib tosylate 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
poly-ADP-ribose polymerase inhibitors 5300 1207456-01-6

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • talazoparib tosylate
  • talazoparib
  • talzenna
  • BMN 673
  • BMN-673
  • BMN-673ts
  • LT 006673
  • LT-00673
  • LT-673
  • MDV-3800
Talazoparib is an inhibitor of poly (ADP-ribose) polymerase (PARP) enzymes, including PARP1 and PARP2, which play a role in DNA repair. In vitro studies with cancer cell lines that harbored defects in DNA repair genes, including BRCA 1 and 2, have shown that talazoparib-induced cytotoxicity may involve inhibition of PARP enzymatic activity and increased formation of PARP-DNA complexes resulting in DNA damage, decreased cell proliferation, and apoptosis. Talazoparib anti-tumor activity was observed in human patient-derived xenograft breast cancer tumor models that expressed mutated or wild-type BRCA 1 and 2.
  • Molecular weight: 380.36
  • Formula: C19H14F2N6O
  • CLOGP: 0.62
  • LIPINSKI: 0
  • HAC: 7
  • HDO: 2
  • TPSA: 84.20
  • ALOGS: -3.58
  • ROTB: 2
  • Status: ONP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

None

ADMET properties:

PropertyValueReference
S (Water solubility) 0.02 mg/mL Bocci G, Oprea TI, Benet LZ
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Bocci G, Oprea TI, Benet LZ

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 1.964 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 5.902 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 32.885 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 1.208 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 27.270 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 43.420 % High 1
herg hERG pIC50 4.370 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 1.104 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 3.459 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 30.930 % High 1
kinase-safety-class GRK2,PDK1,PDK2,PDK4 4
kinase-selectivity-class AURKC,AXL,CAMK2D,CDK9,EGFR,GRK2,PDK1,PIK3CB,PIK3CD 9
mdck-mdr1-bcrp-efflux MDCK-MDR1-BCRP efflux ratio 16.749 High 1
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 15.382 High 1
mh-clint Mouse hepatocyte intrinsic clearance 1.871 High 1
mppb Mouse plasma protein binding (% unbound) 26.410 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 33.574 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pppb Pig plasma protein binding (% unbound) 39.230 % High 1
rat-kpuu-brain Rat brain Kpuu 0.022 % High 1
rh-clint Rat hepatocyte intrinsic clearance 1.496 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 80.970 % High 1
rppb Rat plasma protein binding (% unbound) 28.800 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 78.163 uM High 1

Approvals:

DateAgencyCompanyOrphan
Oct. 16, 2018 FDA PFIZER INC
June 20, 2019 EMA PFIZER EUROPE MA EEIG

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
Neoplasm progression 326.63 59.44 81 1043 44405 90582918
Anaemia 221.49 59.44 100 1024 352702 90274621
Haematotoxicity 149.85 59.44 34 1090 12501 90614822
Febrile neutropenia 86.24 59.44 41 1083 158308 90469015
Thrombocytopenia 81.16 59.44 43 1081 208682 90418641
Second primary malignancy 76.19 59.44 19 1105 10359 90616964
Pancytopenia 68.02 59.44 32 1092 120231 90507092
Metastases to bone 67.61 59.44 21 1103 25484 90601839
Metastases to liver 61.03 59.44 20 1104 28787 90598536

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
Anaemia 194.05 35.30 105 929 280173 42340128
Neoplasm progression 65.25 35.30 25 1009 28975 42591326
Prostatic specific antigen increased 58.32 35.30 20 1014 16905 42603396
Malignant neoplasm progression 51.02 35.30 32 1002 108368 42511933
Thrombocytopenia 43.04 35.30 36 998 190243 42430058
Fatigue 39.05 35.30 50 984 435591 42184710
Pancytopenia 36.79 35.30 27 1007 117716 42502585

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
Anaemia 326.03 42.71 166 1742 546920 110040471
Neoplasm progression 308.45 42.71 90 1818 64505 110522886
Thrombocytopenia 106.37 42.71 69 1839 348816 110238575
Febrile neutropenia 94.90 42.71 62 1846 316705 110270686
Second primary malignancy 85.09 42.71 25 1883 18043 110569348
Haematotoxicity 68.74 42.71 22 1886 21060 110566331
Pancytopenia 67.48 42.71 43 1865 209570 110377821
Platelet count decreased 56.67 42.71 40 1868 230403 110356988
Haemoglobin decreased 56.18 42.71 41 1867 248686 110338705
Metastases to skin 50.95 42.71 11 1897 2288 110585103
Metastases to bone 49.24 42.71 19 1889 31353 110556038
Malignant neoplasm progression 46.86 42.71 32 1876 174535 110412856
Prostatic specific antigen increased 44.68 42.71 14 1894 12497 110574894
Metastases to liver 43.60 42.71 18 1890 35368 110552023

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L01XK04 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
OTHER ANTINEOPLASTIC AGENTS
Poly (ADP-ribose) polymerase (PARP) inhibitors
MeSH PA D000067856 Poly(ADP-ribose) Polymerase Inhibitors
MeSH PA D000970 Antineoplastic Agents
MeSH PA D004791 Enzyme Inhibitors
FDA MoA N0000191622 Poly(ADP-Ribose) Polymerase Inhibitors
FDA EPC N0000191623 Poly(ADP-Ribose) Polymerase Inhibitor
CHEBI has role CHEBI:35610 antineoplastic agent

Related Drugs by ATC class:

L01XK Poly (ADP-ribose) polymerase (PARP) inhibitors 4 drugs
abiraterone acetateniraparibolaparibrucaparib

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

DiseaseRelationSNOMED_IDDOID
Germline BRCA-mutated, HER2-negative metastatic breast cancer indication 767444009




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 11.23 acidic
pKa2 4.1 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 0.1MG BASE TALZENNA PFIZER N211651 June 20, 2023 DISCN CAPSULE ORAL 10780088 July 27, 2029 TREATMENT OF ADULT PATIENTS WITH HRR GENE-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC) IN COMBINATION WITH ENZALUTAMIDE
EQ 0.1MG BASE TALZENNA PFIZER N211651 June 20, 2023 DISCN CAPSULE ORAL 9820985 July 27, 2029 TREATMENT OF ADULT PATIENTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE BREAST CANCER SUSCEPTIBILITY GENE (BRCA)-MUTATED (GBRCAM) HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER
EQ 0.25MG BASE TALZENNA PFIZER N211651 Oct. 16, 2018 DISCN CAPSULE ORAL 10780088 July 27, 2029 TREATMENT OF ADULT PATIENTS WITH HRR GENE-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC) IN COMBINATION WITH ENZALUTAMIDE
EQ 0.25MG BASE TALZENNA PFIZER N211651 Oct. 16, 2018 DISCN CAPSULE ORAL 9820985 July 27, 2029 TREATMENT OF ADULT PATIENTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE BREAST CANCER SUSCEPTIBILITY GENE (BRCA)-MUTATED (GBRCAM) HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER
EQ 0.35MG BASE TALZENNA PFIZER N211651 June 20, 2023 DISCN CAPSULE ORAL 10780088 July 27, 2029 TREATMENT OF ADULT PATIENTS WITH HRR GENE-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC) IN COMBINATION WITH ENZALUTAMIDE
EQ 0.35MG BASE TALZENNA PFIZER N211651 June 20, 2023 DISCN CAPSULE ORAL 9820985 July 27, 2029 TREATMENT OF ADULT PATIENTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE BREAST CANCER SUSCEPTIBILITY GENE (BRCA)-MUTATED (GBRCAM) HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER
EQ 0.5MG BASE TALZENNA PFIZER N211651 Sept. 20, 2021 DISCN CAPSULE ORAL 10780088 July 27, 2029 TREATMENT OF ADULT PATIENTS WITH HRR GENE-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC) IN COMBINATION WITH ENZALUTAMIDE
EQ 0.5MG BASE TALZENNA PFIZER N211651 Sept. 20, 2021 DISCN CAPSULE ORAL 9820985 July 27, 2029 TREATMENT OF ADULT PATIENTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE BREAST CANCER SUSCEPTIBILITY GENE (BRCA)-MUTATED (GBRCAM) HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER
EQ 0.75MG BASE TALZENNA PFIZER N211651 Sept. 20, 2021 DISCN CAPSULE ORAL 9820985 July 27, 2029 TREATMENT OF ADULT PATIENTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE BREAST CANCER SUSCEPTIBILITY GENE (BRCA)-MUTATED (GBRCAM) HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER
EQ 1MG BASE TALZENNA PFIZER N211651 Oct. 16, 2018 DISCN CAPSULE ORAL 9820985 July 27, 2029 TREATMENT OF ADULT PATIENTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE BREAST CANCER SUSCEPTIBILITY GENE (BRCA)-MUTATED (GBRCAM) HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER
EQ 0.1MG BASE TALZENNA PFIZER N217439 March 7, 2024 RX CAPSULE ORAL 10780088 July 27, 2029 TREATMENT OF ADULT PATIENTS WITH HRR GENE-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC) IN COMBINATION WITH ENZALUTAMIDE
EQ 0.1MG BASE TALZENNA PFIZER N217439 March 7, 2024 RX CAPSULE ORAL 9820985 July 27, 2029 TREATMENT OF ADULT PATIENTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE BREAST CANCER SUSCEPTIBILITY GENE (BRCA)-MUTATED (GBRCAM) HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER
EQ 0.25MG BASE TALZENNA PFIZER N217439 March 7, 2024 RX CAPSULE ORAL 10780088 July 27, 2029 TREATMENT OF ADULT PATIENTS WITH HRR GENE-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC) IN COMBINATION WITH ENZALUTAMIDE
EQ 0.25MG BASE TALZENNA PFIZER N217439 March 7, 2024 RX CAPSULE ORAL 9820985 July 27, 2029 TREATMENT OF ADULT PATIENTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE BREAST CANCER SUSCEPTIBILITY GENE (BRCA)-MUTATED (GBRCAM) HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER
EQ 0.35MG BASE TALZENNA PFIZER N217439 March 7, 2024 RX CAPSULE ORAL 10780088 July 27, 2029 TREATMENT OF ADULT PATIENTS WITH HRR GENE-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC) IN COMBINATION WITH ENZALUTAMIDE
EQ 0.35MG BASE TALZENNA PFIZER N217439 March 7, 2024 RX CAPSULE ORAL 9820985 July 27, 2029 TREATMENT OF ADULT PATIENTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE BREAST CANCER SUSCEPTIBILITY GENE (BRCA)-MUTATED (GBRCAM) HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER
EQ 0.5MG BASE TALZENNA PFIZER N217439 March 7, 2024 RX CAPSULE ORAL 10780088 July 27, 2029 TREATMENT OF ADULT PATIENTS WITH HRR GENE-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC) IN COMBINATION WITH ENZALUTAMIDE
EQ 0.5MG BASE TALZENNA PFIZER N217439 March 7, 2024 RX CAPSULE ORAL 9820985 July 27, 2029 TREATMENT OF ADULT PATIENTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE BREAST CANCER SUSCEPTIBILITY GENE (BRCA)-MUTATED (GBRCAM) HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER
EQ 0.75MG BASE TALZENNA PFIZER N217439 March 7, 2024 RX CAPSULE ORAL 10780088 July 27, 2029 TREATMENT OF ADULT PATIENTS WITH HRR GENE-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC) IN COMBINATION WITH ENZALUTAMIDE
EQ 0.75MG BASE TALZENNA PFIZER N217439 March 7, 2024 RX CAPSULE ORAL 9820985 July 27, 2029 TREATMENT OF ADULT PATIENTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE BREAST CANCER SUSCEPTIBILITY GENE (BRCA)-MUTATED (GBRCAM) HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER
EQ 1MG BASE TALZENNA PFIZER N217439 March 7, 2024 RX CAPSULE ORAL 10780088 July 27, 2029 TREATMENT OF ADULT PATIENTS WITH HRR GENE-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC) IN COMBINATION WITH ENZALUTAMIDE
EQ 1MG BASE TALZENNA PFIZER N217439 March 7, 2024 RX CAPSULE ORAL 9820985 July 27, 2029 TREATMENT OF ADULT PATIENTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE BREAST CANCER SUSCEPTIBILITY GENE (BRCA)-MUTATED (GBRCAM) HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
EQ 0.1MG BASE TALZENNA PFIZER N211651 June 20, 2023 DISCN CAPSULE ORAL June 20, 2026 USE OF TALAZOPARIB IN COMBINATION WITH ENZALUTAMIDE FOR THE TREATMENT OF ADULT PATIENTS WITH HOMOLOGOUS RECOMBINATION REPAIR (HRR) GENE-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC).
EQ 0.25MG BASE TALZENNA PFIZER N211651 Oct. 16, 2018 DISCN CAPSULE ORAL June 20, 2026 USE OF TALAZOPARIB IN COMBINATION WITH ENZALUTAMIDE FOR THE TREATMENT OF ADULT PATIENTS WITH HOMOLOGOUS RECOMBINATION REPAIR (HRR) GENE-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC).
EQ 0.5MG BASE TALZENNA PFIZER N211651 Sept. 20, 2021 DISCN CAPSULE ORAL June 20, 2026 USE OF TALAZOPARIB IN COMBINATION WITH ENZALUTAMIDE FOR THE TREATMENT OF ADULT PATIENTS WITH HOMOLOGOUS RECOMBINATION REPAIR (HRR) GENE-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC).
EQ 0.1MG BASE TALZENNA PFIZER N217439 March 7, 2024 RX CAPSULE ORAL June 20, 2026 USE OF TALAZOPARIB IN COMBINATION WITH ENZALUTAMIDE FOR THE TREATMENT OF ADULT PATIENTS WITH HOMOLOGOUS RECOMBINATION REPAIR (HRR) GENE-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC).
EQ 0.25MG BASE TALZENNA PFIZER N217439 March 7, 2024 RX CAPSULE ORAL June 20, 2026 USE OF TALAZOPARIB IN COMBINATION WITH ENZALUTAMIDE FOR THE TREATMENT OF ADULT PATIENTS WITH HOMOLOGOUS RECOMBINATION REPAIR (HRR) GENE-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC).
EQ 0.5MG BASE TALZENNA PFIZER N217439 March 7, 2024 RX CAPSULE ORAL June 20, 2026 USE OF TALAZOPARIB IN COMBINATION WITH ENZALUTAMIDE FOR THE TREATMENT OF ADULT PATIENTS WITH HOMOLOGOUS RECOMBINATION REPAIR (HRR) GENE-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC).

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Poly [ADP-ribose] polymerase 2 Enzyme INHIBITOR Ki 9.06 SCIENTIFIC LITERATURE DRUG LABEL
Poly [ADP-ribose] polymerase 1 Enzyme INHIBITOR Ki 8.92 SCIENTIFIC LITERATURE DRUG LABEL
Poly [ADP-ribose] polymerase 4 Enzyme Kd 9.15 CHEMBL
Poly [ADP-ribose] polymerase 10 Enzyme Kd 5.24 CHEMBL
Tankyrase-1 Enzyme Kd 7.28 CHEMBL
Poly [ADP-ribose] polymerase 8 Enzyme Kd 5.96 CHEMBL
Mono [ADP-ribose] polymerase PARP16 Enzyme Kd 6 CHEMBL
Poly [ADP-ribose] polymerase 3 Enzyme Kd 7.62 CHEMBL

External reference:

IDSource
02WK9U5NZC UNII
4037929 VANDF
C4726799 UMLSCUI
CHEBI:755149 CHEBI
2YQ PDB_CHEM_ID
CHEMBL3137320 ChEMBL_ID
CHEMBL3137318 ChEMBL_ID
135565654 PUBCHEM_CID
D10732 KEGG_DRUG
C586365 MESH_SUPPLEMENTAL_RECORD_UI
DB11760 DRUGBANK_ID
1193867007 SNOMEDCT_US
782199007 SNOMEDCT_US
782211002 SNOMEDCT_US
9868 INN_ID
294344 MMSL
35314 MMSL
d09010 MMSL
017808 NDDF
017809 NDDF
8313 IUPHAR_LIGAND_ID
1373431-65-2 SECONDARY_CAS_RN
2099703 RXNORM
02WK9U5NZC INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Talzenna HUMAN PRESCRIPTION DRUG LABEL 1 0069-0252 CAPSULE, LIQUID FILLED 0.10 mg ORAL NDA 30 sections
Talzenna HUMAN PRESCRIPTION DRUG LABEL 1 0069-0296 CAPSULE 0.25 mg ORAL NDA 30 sections
Talzenna HUMAN PRESCRIPTION DRUG LABEL 1 0069-0353 CAPSULE, LIQUID FILLED 0.25 mg ORAL NDA 30 sections
Talzenna HUMAN PRESCRIPTION DRUG LABEL 1 0069-0454 CAPSULE, LIQUID FILLED 0.35 mg ORAL NDA 30 sections
Talzenna HUMAN PRESCRIPTION DRUG LABEL 1 0069-0546 CAPSULE, LIQUID FILLED 0.50 mg ORAL NDA 30 sections
Talzenna HUMAN PRESCRIPTION DRUG LABEL 1 0069-0655 CAPSULE, LIQUID FILLED 0.75 mg ORAL NDA 30 sections
Talzenna HUMAN PRESCRIPTION DRUG LABEL 1 0069-0757 CAPSULE, LIQUID FILLED 1 mg ORAL NDA 30 sections
Talzenna HUMAN PRESCRIPTION DRUG LABEL 1 0069-1031 CAPSULE 0.10 mg ORAL NDA 30 sections
Talzenna HUMAN PRESCRIPTION DRUG LABEL 1 0069-1195 CAPSULE 1 mg ORAL NDA 30 sections
Talzenna HUMAN PRESCRIPTION DRUG LABEL 1 0069-1235 CAPSULE 0.35 mg ORAL NDA 30 sections
Talzenna HUMAN PRESCRIPTION DRUG LABEL 1 0069-1501 CAPSULE 0.50 mg ORAL NDA 30 sections
Talzenna HUMAN PRESCRIPTION DRUG LABEL 1 0069-1751 CAPSULE 0.75 mg ORAL NDA 30 sections
Talzenna HUMAN PRESCRIPTION DRUG LABEL 1 63539-025 CAPSULE, LIQUID FILLED 0.50 mg ORAL NDA 31 sections
Talzenna HUMAN PRESCRIPTION DRUG LABEL 1 63539-031 CAPSULE, LIQUID FILLED 1 mg ORAL NDA 31 sections
Talzenna HUMAN PRESCRIPTION DRUG LABEL 1 63539-051 CAPSULE 0.50 mg ORAL NDA 30 sections
Talzenna HUMAN PRESCRIPTION DRUG LABEL 1 63539-295 CAPSULE 1 mg ORAL NDA 30 sections