Perrigo Company has received tentative approval from the US Food and Drug Administration (FDA) for the generic version of Picato gel (ingenol mebutate) 0.05%. The submission date of Perrigo's Abbreviated New Drug Application matches the first-to-file date posted on FDA's Paragraph IV Patent Certifications list.
Picato gel (ingenol mebutate) 0.05% is indicated for the topical treatment of actinic keratosis. Branded market sales for the twelve months ending September 2017 were approximately $16 million.
Perrigo executive vice president and president Rx Pharmaceuticals John Wesolowski stated, "This tentative approval, along with the tentative approval previously received for ingenol mebutate gel 0.015%, illustrate the continued dedication of our R&D and regulatory teams as they work to advance our new product pipeline."