← FDA DRUG APPROVALS

FDA NDA · NDA219083

MYQORZO

aficamten

Sponsor: CYTOKINETICS

APPLICATION
NDA219083
TYPE
NDA
ORIGINAL APPROVAL
2025-12-19
LATEST ACTION
2026-02-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

MYQORZO · ReferencePrescription
AFICAMTEN 20MG · TABLET · ORAL
MYQORZO · ReferencePrescription
AFICAMTEN 10MG · TABLET · ORAL
MYQORZO · ReferencePrescription
AFICAMTEN 15MG · TABLET · ORAL
MYQORZO · ReferencePrescription
AFICAMTEN 5MG · TABLET · ORAL

Approval history

2026-02-05REMS · Supplement 1 — Letter ↗AP
2025-12-19Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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