FDA Approves Galderma’s Mirvaso For Treating Facial Redness of Rosacea

Galderma Laboratories L.P. Aug. 26 announced that the Food and Drug Administration has approved Mirvaso (brimonidine) topical gel, 0.33 percent, for treatment of the facial erythema (redness) of rosacea in adults 18 years old or older.

Galderma said it expects Mirvaso to be available in pharmacies in September. Applied once daily, Mirvaso works quickly to reduce the redness and lasts up to 12 hours, the company said.

Mirvaso was approved based on data collected from more than 550 patients enrolled in two phase III clinical studies lasting one month, the company said. The results from both studies showed that adults ...