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.”