Perrigo said Friday that it has received tentative Food and Drug Administration approval for clindamycin phosphate 1.2% and benzoyl peroxide 3.75% gel, a generic version of Onexton Gel from Valeant Pharmaceuticals International. Perrigo said it previously settled litigation with Valeant Pharmaceuticals North America LLC and Dow Pharmaceutical Sciences Inc. for its generic product.
Clindamycin phosphate 1.2% and benzoyl peroxide 3.75% gel is indicated for the topical treatment of acne vulgaris in patients ages 12 and older. Branded market sales for the last 12 months were approximately $115 million, based on data from IQVIA, Perrigo reported.
“This tentative approval is another example of making long-term investments in our extended topicals strategy,” stated John Wesolowski, executive vice president and president of Rx pharmaceuticals at Perrigo. “The Rx team continues to invest in bringing important products to market that provide savings to patients and health care systems.”
Meanwhile, Perrigo said it has gained FDA approval and launched adapalene and benzoyl peroxide gel 0.1%/2.5%, a generic version of Epiduo Gel from Galderma.
Adapalene and benzoyl peroxide gel is used for the treatment of acne vulgaris in patients ages 9 and older. Perrigo said market sales of Epiduo Gel over the last 12 months were about $164 million, according to IQVIA market data.
In the women’s health category, Perrigo has been cleared by the FDA to market estradiol vaginal cream 0.01%, a generic version of Estrace Cream from Allergan.
Perrigo said its Estrace Cream generic will be marketed by its partner Impax Laboratories Inc. and is slated for release in the second quarter of this year.
Estradiol vaginal cream 0.01% is indicated for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy from menopause. Market sales of Estrace Cream over the last 12 months were about $457 million, according to IQVIA data reported by Perrigo.