FDA gives tentative approval to Perrigo’s generic Epiduo Gel

SILVER SPRING, Md. — The Food and Drug Administration has given its tentative approval for Perrigo’s generic of Epiduo Gel (adapalene and benzoyl peroxide 0.1%/2.5%), the company announced Thursday. The drug is indicated to treat acne vulgaris in patients 12 years of age and older. 

 

Annual sales for the product were $379 million for the 12 months ended July 2016. 

 

“This tentative approval is another example of Perrigo's ongoing commitment to developing high-quality value alternatives in important treatment categories,” Perrigo CEO John Hendrickson said.