Perrigo gets tentative approval for generic Prolensa

The Food and Drug Administration has issued tentative approval to Perrigo for its generic of Bausch & Lomb’s Prolensa (bromfenac ophthalmic solution, 0.07%). The product is indicated to treat post-operative inflammation and reduce ocular pain in cataract surgery recipients.

Dublin-based Perrigo said it has previously settled litigation with Bausch & Lomb regarding the product. Prolensa’s U.S. brand sales for past 12 months were $113 million, Perrigo said.

“This tentative approval illustrates the continued dedication of our R&D and regulatory teams as they work to advance our new product pipeline to deliver ‘Quality Affordable Healthcare Products’ to patients around the world,” Perrigo executive vice president and president Rx pharmaceuticals John Wesolowski said.