FDA gives tentative nod for Perrigo’s generic Finacea

BY Sandra Levy

Perrigo has received tentative approval from the Food and Drug Administration for its generic Finacea foam (azelaic acid, 15%). The product is used to treat the inflammatory papules (raised spots) and pustules (pimple-like bumps) of mild to moderate rosacea.

Perrigo previously announced a patent litigation suit with Bayer AG for this product. Subsequently, LEO Pharma A/S acquired Finacea foam (azelaic acid) 15% from Bayer AG and then substituted for Bayer AG as the lead plaintiff in the patent litigation suit concerning the product.

The product had a market value of about $62 million for the 12 months ending January 2019, according to IQVIA.

“Our R&D team continues its diligent efforts to secure regulatory approvals for important new product,” said Perrigo executive vice president and Rx Pharmaceuticals president Sharon Kochan. “This tentative approval reflects our continued dedication to developing specialized, extended topical products for the benefit of patients and payers, as well as further illustrates our commitment to advancing our new product pipeline.”


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