← FDA DRUG APPROVALS

FDA NDA · NDA216793

AKEEGA

niraparib tosylate monohydrate and abiraterone acetate

Sponsor: JANSSEN BIOTECH

APPLICATION
NDA216793
TYPE
NDA
ORIGINAL APPROVAL
2023-08-11
LATEST ACTION
2025-12-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

AKEEGA · ReferencePrescription
ABIRATERONE ACETATE 500MG, NIRAPARIB TOSYLATE EQ 100MG BASE · TABLET · ORAL
AKEEGA · ReferencePrescription
ABIRATERONE ACETATE 500MG, NIRAPARIB TOSYLATE EQ 50MG BASE · TABLET · ORAL

Approval history

2025-12-12Efficacy · Supplement 1 · priority — Letter ↗AP
2023-08-11Type 4 - New Combination · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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