Treats facial angiofibroma associated with tuberous sclerosis. NDA 213478, held by Nobelpharma. Sirolimus.
As of Nov 14, 2026, NDA 213478 (Hyftor), held by Nobelpharma, was first approved by FDA on Mar 22, 2022, with 0 approved supplements and 1 published complete response letter.
HYFTOR is indicated for the treatment of facial angiofibroma associated with tuberous sclerosis in adults and pediatric patients 6 years of age and older.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 22, 2022 | Original applicationNew dosage form · Priority review | Approved |
| Letter | Product | Now |
|---|---|---|
| Aug 13, 2020 | SirolimusProduct Quality, Facility Inspections | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Hyftor0.2% · gel;topical | Sirolimus | 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
