Treats Duchenne muscular dystrophy (DMD). ANDA 219417, held by Aucta. Deflazacort.
As of Nov 14, 2026, ANDA 219417 (Pyquvi), held by Aucta, was first approved by FDA on Jun 30, 2025, with 0 approved supplements and 0 published complete response letters.
PYQUVI 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 |
|---|---|---|---|
| Jun 30, 2025 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Pyquvi22.75MG/ML · suspension;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
