Treats Duchenne muscular dystrophy (DMD). ANDA 216720, held by Upsher Smith Labs. Deflazacort.
As of Nov 14, 2026, ANDA 216720 (Deflazacort), held by Upsher Smith Labs, was first approved by FDA on Nov 5, 2024, with 1 approved supplement 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 |
|---|---|---|---|
| Nov 5, 2024 | 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 |
| Nov 21, 2025 | Supplement 3Labeling · Standard review | Approved | None posted |
| Nov 5, 2024 | Original application | Approved | None posted |
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
