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# Foamix NDA Accepted for Acne Treatment
- URL: https://www.fdaweb.com/foamix-nda-accepted-for-acne-treatment/
- Published: 2019-03-07T12:00:00.000Z
- Updated: 2026-09-15T01:10:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143548

FDA has accepted for review a Foamix Pharmaceuticals NDA for FMX101 (minocycline foam, 4%) for treating inflammatory lesions of non-nodular moderate-to-severe acne vulgaris in patients aged nine years and older. The agency has set a user fee review action target of 10/20.

The submission is supported by data from two Phase 3 trials, FX2014-05 and FX2017-22, that met both co-primary endpoints — demonstrating statistically significant improvements in inflammatory lesion count and Investigator Global Assessment treatment success, according to the company. No treatment-related serious adverse events were identified in the clinical development program, and the most common adverse event was upper respiratory tract infection.