SILVER SPRING, Md. — The Food and Drug Administration has granted Perrigo tentative approval for its generic of Mirvaso Gel (brimonidine topical gel, 0.33). Perrigo said it had previously settled litigation with Galderma Laboratories and Nestle Skin Health for the product.
The drug is indicated to treat persistent (nontransient) erythema of rosacea in adults ages 18 years and older. It had a U.S. market size of $31 million for the 12 months ended June 2016.
“The R&D team continues its relentless efforts to achieve regulatory approvals for new products,” Perrigo EVP and president Rx Pharmaceuticals John Wesolowski said. “This tentative approval reflects our continued dedication to developing extended topical products for patients.”