Treats symptomatic obstructive hypertrophic cardiomyopathy (HCM). NDA 214998, held by Bristol. Mavacamten.
As of Nov 14, 2026, NDA 214998 (Camzyos), held by Bristol, was first approved by FDA on Apr 28, 2022, with 7 approved supplements and 0 published complete response letters.
CAMZYOS is indicated for the treatment of adults and pediatric patients weighing 30 kg or more with symptomatic obstructive hypertrophic cardiomyopathy (HCM) to improve functional capacity and symptoms.
| Sep 30, 2026 | Supplement 13Efficacy (new indication or use) · Priority review | Approved | |
| Apr 17, 2025 | Supplement 10Efficacy (new indication or use) · Standard review | Approved | |
| Jun 15, 2023 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Apr 28, 2022 | Original applicationNew molecular entity · Standard review | Approved |
| Camzyos2.5MG · capsule;oral | Mavacamten | RxReference drug |
| Camzyos5MG · capsule;oral | Mavacamten | RxReference drug |
| Camzyos10MG · capsule;oral | Mavacamten | RxReference drug |
| Camzyos15MG · capsule;oral | Mavacamten | RxReference drug |
| Camzyos1MG · capsule;oral | Mavacamten | RxReference drug |
| Sep 30, 2026 | Supplement 13Efficacy (new indication or use) · Priority review | Approved | |
| Apr 17, 2025 | Supplement 10Efficacy (new indication or use) · Standard review | Approved | |
| Apr 30, 2024 | Supplement 9Labeling · Standard review | Approved | |
| Dec 19, 2023 | Supplement 8REMS | Approved | |
| Jun 15, 2023 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Jan 13, 2023 | Supplement 4REMS | Approved | |
| Nov 22, 2022 | Supplement 3REMS | Approved | |
| Apr 28, 2022 | Original applicationNew molecular entity · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
