Perrigo Company plc announced it has received tentative approval from the U.S. Food and Drug Administration for the generic version of Epiduo® Gel (adapalene and benzoyl peroxide 0.1%/2.5%).
Epiduo® Gel (adapalene and benzoyl peroxide 0.1%/2.5%) is indicated for the treatment of acne vulgaris in patients 12 years of age and older. Annual sales for the 12 months ending July 2016 were $379 million.
Perrigo's CEO John T. Hendrickson stated, "This tentative approval is another example of Perrigo's ongoing commitment to developing high quality value alternatives in important treatment categories. The Rx team continues to leverage Perrigo's development capabilities in order to deliver Quality Affordable Healthcare Products® to our customers and consumers around the world."