> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Foamix Pharma NDA for Rosacea Foam Filed
- URL: https://www.fdaweb.com/foamix-pharma-nda-for-rosacea-foam-filed/
- Published: 2019-10-17T12:00:00.000Z
- Updated: 2026-09-15T01:57:22.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145279

FDA has accepted for review a Foamix Pharmaceuticals NDA for FMX103 (minocycline topical foam 1.5%) topical foam for treating moderate-to-severe papulopustular rosacea in adults. The agency has set a user fee review action target date of 6/2/2020.

The submission is supported by data from two 12-week double-blind Phase 3 efficacy and safety trials (Studies FX2016-11 and FX2016-12) and one 40-week open-label safety extension trial (Study FX2016-13). The data demonstrated “statistically significant improvements in inflammatory lesion count and Investigator Global Assessment treatment success,” the company says. “No treatment-related serious adverse events have been identified in the FMX103 clinical development program, where the most common adverse event was upper respiratory tract infection.”