Perrigo Company plc received final approval from the U.S. Food and Drug Administration and has launched an AB-rated generic version of Epiduo (adapalene and benzoyl peroxide) Gel, 0.1%/2.5%, indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.
The company also received final FDA approval for the generic version of Estrace Cream (estradiol vaginal cream, USP, 0.01%), a product that will be marketed by Perrigo’s partner, Impax Laboratories, Inc., and is currently expected to launch in the second quarter of this year. Estrace Cream is indicated in the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause.
Market sales of Epiduo Gel over the last 12 months were approximately $164 million, according to IMS Health, which placed market sales of Estrace Cream during the same period at approximately $457 million.
Perrigo Company plc was founded in 1887 as a packager of home remedies and has built a unique business model that is described as the convergence of a fast-moving consumer goods company, a high-quality pharmaceutical manufacturing organization, and a supply chain network.
The company is one of the world’s largest manufacturers of over-the-counter (OTC) healthcare products and suppliers of infant formulas for the store brand market. It also is a provider of branded OTC products throughout Europe and the U.S., as well as a producer of “extended topical” prescription drugs.
Perrigo, headquartered in Ireland, sells its products in North America and Europe, as well as in other markets, including Australia, Israel, and China.
Filed Under: Drug Discovery