Treats Duchenne muscular dystrophy (DMD). NDA 213026, held by Sarepta Theraps Inc. Casimersen.
As of Nov 14, 2026, NDA 213026 (Amondys 45), held by Sarepta Theraps Inc, was first approved by FDA on Feb 25, 2021, with 3 approved supplements and 0 published complete response letters.
AMONDYS 45 is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 45 skipping. This indication is approved under accelerated approval based on an increase in dystrophin production in skeletal muscle observed in patients treated with AMONDYS 45. Continued approval for this indication may be contingent upon verification of a clinical benefit in confirmatory trials.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 25, 2021 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Amondys 45100MG/2ML (50MG/ML) · solution;intravenous | Casimersen | RxReference drug |
| Jan 6, 2026 | Supplement 16Labeling · Standard review | Approved | |
| Jul 11, 2024 | Supplement 8Labeling · Standard review | Approved | |
| Mar 23, 2023 | Supplement 5Labeling · Standard review | Approved | |
| Feb 25, 2021 | Original applicationNew molecular entity · Priority 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
