FDA grants tentative approval for Perrigo’s Onexton Gel

Perrigo Company asserted that it sought tentative approval from the U.S Food and Drug Administration for the generic version of Onexton Gel (clindamycin phosphate 1.2% and benzoyl peroxide 3.75%). Onexton Gel (clindamycin phosphate 1.2% and benzoyl peroxide 3.75%) is a prescription medicine indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. Branded market sales for the last 12 months were pegged at $115 million.

Perrigo Executive Vice President and President Rx Pharmaceuticals John Wesolowski stated claimed “This tentative approval is another example of making long-term investments in our extended topicals strategy. The Rx team continues to invest in bringing important products to market that provide savings to patients and healthcare systems.”