FDA approves 2 Perrigo topical generics
The Food and Drug Administration has approved two topical generics from Perrigo, with one of them launching immediately. The agency approved the company’s generic of Estrace Cream (estradiol vaginal cream, 0.01%) and Epiduo Gel (adapalene and benzoyl peroxide gel, 0.1/2.5%).
The Epiduo Gel generic — a topical treatment for acne vulgaris in patients 9-years-old and older — will launch immediately, the company said. The product had U.S. sales of roughly $164 million for the past 12 months, according to IQVIA data.
The Estrace Cream generic is indicated to treat severe symptoms of vulvar and vaginal atrophy due to menopause, and the company said that its partner Impax Labs would be marketing the generic. Perrigo said the product would launch in the second quarter of 2018. The drug had U.S. sales of roughly $457 million for the past 12 months, based on IQVIA data.
The Epiduo Gel generic — a topical treatment for acne vulgaris in patients 9-years-old and older — will launch immediately, the company said. The product had U.S. sales of roughly $164 million for the past 12 months, according to IQVIA data.
The Estrace Cream generic is indicated to treat severe symptoms of vulvar and vaginal atrophy due to menopause, and the company said that its partner Impax Labs would be marketing the generic. Perrigo said the product would launch in the second quarter of 2018. The drug had U.S. sales of roughly $457 million for the past 12 months, based on IQVIA data.