ALLEGAN, Mich. — Perrigo Co. has received approval from the Food and Drug Administration for butoconazole nitrate 2% vaginal cream.
The company said Tuesday that the antifungal medication, used to treat vaginal yeast infections, is the generic equivalent of Gynazole-1.
Gynazole-1 was voluntarily discontinued by KV Pharmaceutical Co. in January 2009 because of manufacturing issues, Perrigo reported. Before its production was halted, Gynazole-1 had annual sales of about $28 million, according to data from Wolters Kluwer Health.
Perrigo said it was the first applicant to submit a substantially complete abbreviated new drug application (ANDA) with a paragraph IV certification and is entitled to 180 days of marketing exclusivity.
The company added that it’s working exclusively with KV Pharmaceutical on a collaboration to launch the product by the end of this year.
"This approval exemplifies how our robust research and development abilities in the areas of creams, foams, gels and liquids translate into new product approvals," stated Joseph Papa, chairman and chief executive officer of Perrigo."
