Perrigo has received tentative approval from the U.S. Food and Drug Administration (FDA) for the generic version of Prolensa (bromfenac ophthalmic solution) 0.07%. Perrigo previously settled litigation with Bausch & Lomb for this product.
Prolensa (bromfenac ophthalmic solution) 0.07% is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. Branded market sales for the last twelve months were approximately $113 million.
"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.