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news.Auxilium Pharmaceuticals, a specialty biopharmaceutical company, has reported that the FDA has accepted for filing and granted priority review status to its biologics license application for Xiaflex, a novel, orphan-designated, biologic for the treatment of Dupuytren's contracture.
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Under the Prescription Drug User Fee Act, the FDA is expected to take action on the application by August 28, 2009.
Armando Anido, CEO and president of Auxilium, said: “We are pleased that the FDA has granted priority review for our Xiaflex biologics license application (BLA). We believe this designation emphasizes the significant need for a non-surgical treatment alternative for Dupuytren’s contracture.
“We look forward to working with the FDA as it reviews the application. If approved, we are planning for a US launch approximately 60 days following Xiaflex approval.”