Perrigo Company has announced it has received tentative approval from the US Food and Drug Administration for the generic version of Mirvaso (brimonidine) topical gel 0.33%. Perrigo previously settled litigation with Galderma Laboratories, L.P. and Nestle Skin Health S.A. for this product.

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. Annual market sales for the 12 months ending June 2016 were $31 million.

Perrigo executive vice president and president Rx Pharmaceuticals John Wesolowski stated, "The R&D team continues its relentless efforts to achieve regulatory approvals for new products. This tentative approval reflects our continued dedication to developing extended topical products for patients."