Perrigo Receives Tentative FDA Approval

Perrigo has received 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%). 

Perrigo previously settled litigation with Valeant Pharmaceuticals North America LLC and Dow Pharmaceutical Sciences for the product. 

Onexton Gel 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 approximately $115 million.

Perrigo’s executive vice president, John Wesolowski said, “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.”