SILVER SPRING, Md. — The Food and Drug Administration has granted tentative approval to Perrigo for its generic of actinic keratosis treatment Picato Gel (ingenol mebutate, 0.015%). The company said that its submission date made it the first to file for a generic of this product.
“This tentative approval illustrates the hard work and dedication of our R&D and regulatory teams as they continue to advance our new product pipeline,” Perrigo EVP and president Rx pharmaceuticals John Wesolowski said. “The Rx team remains committed to delivering savings for patients and families.”
The drug had U.S. sales of roughly $51 million for the 12 months ended August 2017, according to QuintilesIMS data.