Treats Duchenne muscular dystrophy (DMD). ANDA 219254, held by Zydus Lifesciences. Deflazacort.
As of Nov 14, 2026, ANDA 219254 (Jaythari), held by Zydus Lifesciences, was first approved by FDA on Apr 8, 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 2 years of age and older.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 8, 2025 | Original application | Approved | None posted |
| Jaythari6MG · tablet;oral | Deflazacort | Rx |
| Jaythari18MG · tablet;oral | Deflazacort | Rx |
| Jaythari30MG · tablet;oral | Deflazacort | Rx |
| Jaythari36MG · 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
