Perrigo’s generic Onexton Gel gets tentative FDA nod

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Perrigo’s generic Onexton Gel gets tentative FDA nod

By David Salazar - 01/29/2018
The Food and Drug Administration has tentatively approved Perrigo’s generic Onexton Gel (clindamycin phosphate 1.2% and benzoyl peroxide 3.75%). Perrigo said that it had previously settled litigation with Valeant Pharmaceuticals North America and Dow Pharmaceutical Sciences for the product.

“This tentative approval is another example of making long-term investments in our extended topicals strategy,” Perrigo executive vice president and president Rx pharmaceuticals John Wesolowski said. “The Rx team continues to invest in bringing important products to market that provide savings to patients and healthcare systems.”

Onexton Gel is indicated to treat acne vulgaris in patients ages 12 years and older. The product had branded sales of $115 million for the past 12 months, Perrigo said.

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