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# Foamix Pharmaceuticals NDA for Rosacea Foam
- URL: https://www.fdaweb.com/foamix-pharmaceuticals-nda-for-rosacea-foam/
- Published: 2019-08-05T12:00:00.000Z
- Updated: 2026-09-15T01:41:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144690

Foamix Pharmaceuticals has submitted an NDA seeking approval for FMX103 foam for treating moderate-to-severe papulopustular rosacea in patients aged 18 years and older. The NDA submission is supported by data from two Phase 3 clinical trials, FX2016-11 and FX2016-12\. “In these trials, FMX103 achieved both co-primary endpoints, demonstrating statistically significant improvements in inflammatory lesion count and Investigator Global Assessment (IGA) treatment success,” the company says. On the safety side, FMX103 was shown to be generally favorable and consistent throughout the clinical development program, it adds.