Treats Duchenne muscular dystrophy (DMD). ANDA 217173, held by Amneal. Deflazacort.
As of Nov 14, 2026, ANDA 217173 (Deflazacort), held by Amneal, was first approved by FDA on Dec 12, 2025, with 0 approved supplements and 0 published complete response letters.
Deflazacort tablets are indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older. Additional pediatric use information is approved for PTC Therapeutics, Inc.'s Emflaza (deflazacort) tablets. However, due to PTC Therapeutics, Inc.'s marketing exclusivity rights, this drug product is not labeled with that information.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 12, 2025 | Original application | Approved | None posted |
| Deflazacort6MG · tablet;oral | Deflazacort | Rx |
| Deflazacort18MG · tablet;oral | Deflazacort | Rx |
| Deflazacort30MG · tablet;oral | Deflazacort | Rx |
| Deflazacort36MG · tablet;oral | Deflazacort | Rx |
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
