Foamix Pharmaceuticals Ltd. submitted an application seeking U.S. Food and Drug Administration approval for its acne drug FMX101.
The Israel-based company is seeking the regulator's nod for FMX101 as a therapy for inflammatory lesions of non-nodular moderate-to-severe acne vulgaris in patients aged 9 years and older.
The application is based on the results of two late-stage trials, called FX2014-05 and FX2017-22.