Treats Duchenne muscular dystrophy (DMD). NDA 208685, held by Ptc Therap. Deflazacort.
As of Nov 13, 2026, NDA 208685 (Emflaza), held by Ptc Therap, was first approved by FDA on Feb 9, 2017, with 4 approved supplements and 0 published complete response letters.
EMFLAZA is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 7, 2019 | Supplement 3Efficacy (new indication or use) · Priority review | Approved | |
| Feb 9, 2017 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Emflaza22.75MG/ML · suspension;oral | Deflazacort | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 5, 2024 | Supplement 7Labeling · Standard review | Approved | |
| Jun 29, 2021 | Supplement 5Labeling · Standard review | Approved | |
| Jul 10, 2020 | Supplement 4Labeling · Standard review | Approved | |
| Jun 7, 2019 | Supplement 3Efficacy (new indication or use) · Priority review | Approved | |
| Feb 9, 2017 | Original applicationNew molecular entity · Priority review | Approved |
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
