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Perrigo Receives FDA Approval for Butoconazole Nitrate 2% Vaginal Cream
ALLEGAN, Mich., May 22, 2012 /PRNewswire via COMTEX/ -- Perrigo Company /quotes/zigman/77083/quotes/nls/prgo PRGO -1.35% today 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 on a collaboration to launch the product by the end of calendar year 2012.
So this is how KV are going to get Clindesse back to the market - they obviously struck a deal with Perrigo. I am surprised that the market has not reacted positvely to this news as the return of Clindesse will add $30-40M in sales at 85% GP - this could be enough to prevent BK.
ALLEGAN, Mich., May 22, 2012 /PRNewswire via COMTEX/ -- Perrigo Company /quotes/zigman/77083/quotes/nls/prgo PRGO -1.35% today 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 on a collaboration to launch the product by the end of calendar year 2012.
So this is how KV are going to get Clindesse back to the market - they obviously struck a deal with Perrigo. I am surprised that the market has not reacted positvely to this news as the return of Clindesse will add $30-40M in sales at 85% GP - this could be enough to prevent BK.