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ALLEGAN, Mich. — The Food and Drug Administration has approved a generic treatment made by Perrigo for fungal infections of the vagina, the company said.
Perrigo announced the approval of butoconazole nitrate 2% vaginal cream, a generic version of KV Pharmaceutical's Gynazole-1, used to treat vulvovaginal candidiasis, an infection caused by Candida fungus. KV voluntarily discontinued selling the drug in January 2009 due to manufacturing problems.
The drug maker said it was the first company to file a complete regulatory application for the drug with the FDA, thus entitling it to 180 days of market exclusivity. Perrigo will launch the drug at the end of the year under a collaboration with KV.
Gynazole had annual sales of $28 million before its voluntary discontinuation, according to Wolters Kluwer Health.