Perrigo (PRGO) Gets FDA Approval for Generic Gynazole 1
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Perrigo Company (Nasdaq: PRGO) announced that it has received final approval from the U.S. 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 (NYSE: KV-A) on a collaboration to launch the product by the end of calendar year 2012.
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 (NYSE: KV-A) on a collaboration to launch the product by the end of calendar year 2012.
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