FDA to Review Fibrocell Science, Inc.’s (FCSC.OB) Complete Response Submission for Azficel-T
Fibrocell Science, Inc., a biotechnology company focused on the development of autologous (personalized) cell therapies for aesthetic, medical and scientific applications, announced this morning that the U.S. Food & Drug Administration (FDA) has accepted for review its complete response submission for azficel-T, proposed brand name laViv®. The product is designed to treat moderate to severe nasolabial folds and wrinkles. The Prescription Drug User Fee Act (PDUFA) date has been set for June 22, 2011. “We are pleased that our complete response was accepted and look forward to working closely with the FDA through the review process,” stated David Pernock, Fibrocell…