Treats Duchenne muscular dystrophy (DMD). ANDA 220524, held by Hikma. Deflazacort.
As of Nov 14, 2026, ANDA 220524 (Deflazacort), held by Hikma, was first approved by FDA on Sep 18, 2026, with 0 approved supplements and 0 published complete response letters.
Deflazacort tablets are indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 18, 2026 | 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
