Treats primary axillary hyperhidrosis. NDA 217347, held by Botanix Sb. Sofpironium Bromide.
As of Nov 13, 2026, NDA 217347 (Sofdra), held by Botanix Sb, was first approved by FDA on Jun 18, 2024, with 0 approved supplements and 1 published complete response letter.
SOFDRA is indicated for the treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 18, 2024 | Original applicationNew molecular entity · Standard review | Approved |
| Letter | Product | Now |
|---|---|---|
| Sep 22, 2023 | Sofpironium bromideHuman Factors | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| SofdraEQ 12.45% BASE (EQ 72MG BASE/ACTUATION) · gel, metered;topical | Sofpironium Bromide | 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
