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Foamix files for US FDA approval of rosacea treatment

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Foamix files for US FDA approval of rosacea treatment

Foamix Pharmaceuticals Ltd. has submitted a new drug application to the U.S. Food and Drug Administration seeking approval for its experimental skin condition drug FMX103.

If approved, FMX103 would treat moderate-to-severe papulopustular rosacea in adults, a condition characterized by redness and visible blood vessels in the face. Rosacea, often mistaken for acne, can also cause small, red, pus-filled bumps to form.

The Israeli dermatology company's application is based on positive data from two late-stage studies, Foamix said in an Aug. 5 press release.

According to Foamix, approximately 16 million individuals in the U.S. have rosacea, and about 85% experience sensitivity to the available treatment options.