Perrigo gets tentative approval for second strength of Picato Gel generic

DUBLIN — Little more than a week after its first tentative approval for its 0.015% formulation of its Picato Gel generic, Perrigo has gained tentative approval from the Food and Drug Administration for a higher strength generic. The company’s ingenol mebutate, 0.05%, is indicated to treat actinic keratosis.

“This tentative approval, along with the tentative approval previously received for ingenol mebutate gel 0.015%, illustrates the continued dedication of our [research and development] and regulatory teams as they work to advance our new product pipeline.” Perrigo president Rx pharmaceuticals John Wesolowski said.

The drug had U.S. sales of approximately $16 million, Perrigo said. The company said that its submission date made it the first to file for a generic of this product.