Treats wounds associated with dystrophic and junctional epidermolysis bullosa (EB). NDA 215064, held by Chiesi. Birch Triterpenes.
As of Nov 14, 2026, NDA 215064 (Filsuvez), held by Chiesi, was first approved by FDA on Dec 18, 2023, with 0 approved supplements and 1 published complete response letter.
FILSUVEZ is indicated for the treatment of wounds associated with dystrophic and junctional epidermolysis bullosa (EB) in adult and pediatric patients 6 months of age and older.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 18, 2023 | Original applicationNew molecular entity · Priority review | Approved |
| Letter | Product | Now |
|---|---|---|
| Feb 26, 2022 | Filsuvez (birch triterpenes)Clinical, Julie G Beitz | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Filsuvez10% · gel;topical | Birch Triterpenes | RxReference drug |
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
