Perrigo Company, a leading global healthcare supplier that develops, manufactures and distributes OTC and generic prescription pharmaceuticals, infant formulas, nutritional products, and APIs, has received final approval from the US Food and Drug Administration for its abbreviated new drug application (ANDA) for butoconazole nitrate 2% vaginal cream, the generic equivalent of Gynazole·1.
Perrigo was the first applicant to submit a substantially complete ANDA with a paragraph IV certification and is entitled to 180-days of marketing exclusivity. Perrigo is working exclusively with KV Pharmaceutical Company on a collaboration to launch the product by the end of calendar year 2012.
Gynazole·1 (butoconazole nitrate) vaginal cream, 2%, is indicated for the local treatment of vulvovaginal candidiasis (infections cause by Candida). Prior to the voluntary discontinuation of the product in January 2009 due to manufacturing issues at KV Pharmaceutical, Gynazole·1 annual sales were approximately $28 million, as measured by Wolters Kluwer Health.
Perrigo’s chairman, president and chief executive officer, Joseph C. Papa, stated, “This approval once again exemplifies how our robust research and development abilities in the areas of creams, foams, gels and liquids translate into new product approvals. Perrigo is committed to making quality healthcare more accessible and affordable for our customers.”