Application Nr Approved Date Route Status External Links
NDA211651 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Talzenna Is Indicated For The 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. Select Patients For Therapy Based On An Fda-Approved Companion Diagnostic For Talzenna [See Dosage And Administration (2.1) ] . Talzenna Is A Poly (Adp-Ribose) Polymerase (Parp) Inhibitor Indicated For The Treatment Of Adult Patients With Deleterious Or Suspected Deleterious Germline Brca-Mutated ( Gbrcam ) Her2-Negative Locally Advanced Or Metastatic Breast Cancer. Select Patients For Therapy Based On An Fda-Approved Companion Diagnostic For Talzenna. ( 1 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Talazoparib Tosylate TALAZOPARIB TOSYLATE ZINC6427042

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