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Perrigo Receives Tentative FDA Approval

For the generic version Onexton Gel (clindamycin phosphate 1.2% and benzoyl peroxide 3.75%)

By: Betsy Louda

, Contract Pharma

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.”

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