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 Science Chairman and CEO. “If approved, azficel-T will be the first and only personalized cell-based aesthetic treatment.”
The company’s unique approach results in a replenishment of the patient’s own fibroblasts, the cells responsible for releasing collagen, elastin and hyaluronic acid to add strength and elasticity to the skin. Fibrocell Science anticipates conducting studies in additional areas such as further aesthetic applications and for treatment of restrictive burn scars, acne scars, and periodontal disease.
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