Treats Duchenne muscular dystrophy (DMD). ANDA 216992, held by Upsher Smith Labs. Deflazacort.
As of Nov 14, 2026, ANDA 216992 (Deflazacort), held by Upsher Smith Labs, was first approved by FDA on Aug 11, 2025, with 1 approved supplement and 0 published complete response letters.
KYMBEE is 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) oral suspension. However, due to PTC Therapeutics, Inc.'s marketing exclusivity rights, this drug product is not labeled with that information.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 11, 2025 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Deflazacort22.75MG/ML · suspension;oral | Deflazacort | Rx |
| Apr 9, 2026 | Supplement 1Labeling · Standard review | Approved | None posted |
| Aug 11, 2025 | 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
