Mirvaso is FDA approved for Rosacea
Galderma Laboratories, L.P. today announced that the FDA has approved Mirvaso (brimonidine) topical gel, 0.33% for the topical treatment of the facial erythema (redness) of Rosacea in adults 18 years of age or older. Applied once-daily, Mirvaso works quickly to reduce the redness of Rosacea and lasts up to 12 hours. Galderma expects Mirvaso to be available in pharmacies September 2013.
The approval of Mirvaso was based on data collected from more than 550 patients enrolled in two phase III clinical studies of one-month duration. The results from both studies showed that adults who used Mirvaso demonstrated significantly greater improvement in the facial redness of Rosacea than vehicle gel.In addition, a long-term study in 276 subjects that used Mirvaso for up to 12-months was also conducted. Mirvaso is a topical gel that may work by constricting the dilated facial blood vessels to reduce the redness of Rosacea.
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