Treats Duchenne muscular dystrophy (DMD). ANDA 217741, held by Sun Pharm. Deflazacort.
As of Nov 14, 2026, ANDA 217741 (Deflazacort), held by Sun Pharm, was first approved by FDA on Mar 18, 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 TM (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 |
|---|---|---|---|
| Mar 18, 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
