FDA approves Galderma's Mirvaso for redness of rosacea

Drug expected to become available in September

FORT WORTH, Texas — The Food and Drug Administration has approved a drug made by Galderma Labs for treating a side effect of rosacea in adults, the company said.

Galderma announced the approval of Mirvaso (brimonidine) topical gel in the 0.33% strength for the topical treatment of facial erythema of rosacea. The drug is applied once per day to reduce redness and lasts up to 12 hours. The company expects the drug to become available in pharmacies next month.

"Facial redness is the most common symptom of rosacea, but until now, physicians have been without prescription treatment options to specifically address this patient need," University of Louisville medical professor and lead investigator in the late-stage clinical trials of the drug Mark Jackson said. "The FDA approval of Mirvaso marks a turning point in rosacea treatment: We are now able to provide patients who deal with the daily frustrations caused by the redness of rosacea with an effective therapy."

 

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