Perrigo awarded tentative approval from US FDA for generic version of Mirvaso Gel to treat rosacea
7 August 2017 -

Healthcare company Perrigo Company plc (NYSE:PRGO)(TASE:PRGO) reported on Friday the receipt of tentative approval from the US Food and Drug Administration for the generic version of Mirvaso (brimonidine) topical gel 0.33% for the treatment of rosacea.

The company said it had earlier settled litigation with Galderma Laboratories LP and Nestle Skin Health SA for Mirvaso (brimonidine) topical gel 0.33%.

According to the company, the Mirvaso (brimonidine) topical gel 0.33% is indicated for the topical treatment of persistent (nontransient) erythema of rosacea in adults 18 years of age or older.

For the 12 months ending June 2016, the annual market sales for Mirvaso® (brimonidine) topical gel 0.33% were USD31m, concluded the company .