← FDA DRUG APPROVALS

FDA NDA · NDA214998

CAMZYOS

mavacamten

Sponsor: BRISTOL

APPLICATION
NDA214998
TYPE
NDA
ORIGINAL APPROVAL
2022-04-28
LATEST ACTION
2025-04-17
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

CAMZYOS · ReferencePrescription
MAVACAMTEN 2.5MG · CAPSULE · ORAL
CAMZYOS · ReferencePrescription
MAVACAMTEN 15MG · CAPSULE · ORAL
CAMZYOS · ReferencePrescription
MAVACAMTEN 5MG · CAPSULE · ORAL
CAMZYOS · ReferencePrescription
MAVACAMTEN 10MG · CAPSULE · ORAL

Approval history

2025-04-17Efficacy · Supplement 10 · standard — Label ↗AP
2024-04-30Labeling · Supplement 9 · standard — Letter ↗AP
2023-12-19REMS · Supplement 8 — Letter ↗AP
2023-06-15Efficacy · Supplement 1 · standard — Label ↗AP
2023-01-13REMS · Supplement 4 — Letter ↗AP
2022-11-22REMS · Supplement 3 — Letter ↗AP
2022-04-28Type 1 - New Molecular Entity · Original · standard — Label ↗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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