Generics
Perrigo wins US FDA's tentative approval for first-to-file generic Picato Gel .015%
25 October 2017 -

Healthcare company Perrigo Company plc (NYSE:PRGO)(TASE:PRGO) reported on Tuesday the receipt of tentative approval from the US Food and Drug Administration (FDA) for the generic version of Picato Gel (ingenol mebutate) 0.015% indicated for the topical treatment of actinic keratosis.

This US FDA submission date of the company's abbreviated new drug application matches the first-to-file date on the FDA's Paragraph IV Patent Certifications list.

For the 12 months ending August 2017, the branded market sales were approximately USD51m, added the company.

An actinic keratosis (AK), also known as a solar keratosis, is a crusty, scaly growth caused by damage from exposure to ultraviolet (UV) radiation. AK is considered a precancer because if left alone, it could develop into a skin cancer, most often the second most common form of the disease, squamous cell carcinoma (SCC).

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