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# FDA Tentative Approval for Perrigo Epiduo
- URL: https://www.fdaweb.com/fda-tentative-approval-for-perrigo-epiduo/
- Published: 2016-09-01T12:00:00.000Z
- Updated: 2026-09-14T21:28:57.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136683

FDA has granted Perrigo tentative ANDA approval for a generic version of Gladerma’s Epiduo Gel (adapalene and benzoyl peroxide 0.1%/2.5%), indicated for treating acne vulgaris in patients 12 years of age and older. Annual sales for the brand product are about $379 million. According to FDA’s *Orange Book*, there are several patents expiring in 2027.