Perrigo Co. (PRGO) announced Tuesday that it has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug application or ANDA for butoconazole nitrate 2% vaginal cream, the generic equivalent of Gynazole•1
Perrigo said it 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 noted that it 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.
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