← FDA DRUG APPROVALS

FDA NDA · NDA219616

AVMAPKI FAKZYNJA CO-PACK

avutometinib potassium and defactinib hydrochloride

Sponsor: VERASTEM INC

APPLICATION
NDA219616
TYPE
NDA
ORIGINAL APPROVAL
2025-05-08
LATEST ACTION
2025-05-08
ROUTE
ORAL
DOSAGE FORM
CAPSULE, TABLET
MARKETING STATUS
Prescription

Products

AVMAPKI FAKZYNJA CO-PACK (COPACKAGED) · ReferencePrescription
AVUTOMETINIB POTASSIUM EQ 0.8MG BASE, DEFACTINIB HYDROCHLORIDE EQ 200MG BASE · CAPSULE, TABLET · ORAL

Approval history

2025-05-08Type 1 - New Molecular Entity · Original · priority — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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