FDA grants tentative approval for generic Prolensa
The FDA has granted tentative approval to Perrigo Company plc for its generic version of Prolensa, according to a company press release.
Prolensa (bromfenac ophthalmic solution 0.07%, Bausch + Lomb), a nonsteroidal anti-inflammatory drug for treating inflammation and ocular pain in cataract surgery patients, had branded market sales of $113 million in the past 12 months, according to the Perrigo press release.
The tentative approval demonstrates the company’s “continued dedication” to delivering “quality affordable health care products,” the company’s executive vice president and president of Rx Pharmaceuticals teams John Wesolowski said in the release.