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# Perrigo Tentative Approval for Acne Generic Drug
- URL: https://www.fdaweb.com/perrigo-tentative-approval-for-acne-generic-drug/
- Published: 2018-01-26T12:00:00.000Z
- Updated: 2026-09-14T23:17:38.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140610

FDA has tentatively approved a Perrigo ANDA for a generic version of Valeant Pharmaceutical’s Onexton Gel (clindamycin phosphate 1.2% and benzoyl peroxide 3.75%), indicated for topical treatment of acne vulgaris in patients 12 years of age and older. Branded market sales for the last 12 months were about $115 million. Perrigo previously settled litigation with Valeant and Dow Pharmaceutical Sciences involving the product, and [details of the settlement](http://perrigo.investorroom.com/2017-10-26-Perrigo-Announces-Patent-Litigation-Settlement-for-the-Generic-Version-of-Onexton-R-Gel?ref=fdaweb.com) are being kept confidential.