Fibrocell Science Inc. says it has submitted more information to the U.S. Food & Drug Administration after receiving a complete response letter regarding a wrinkle treatment.
The Exton biotech company formerly known as Isolagen Inc., which emerged from bankruptcy last year with a new name, is seeking approval for azficel-T, which is being developed to treat wrinkles that run from the side of the nose to the corner of the mouth. The medication would be marketed under the name Laviv.
A complete response letter indicates that more information must be submitted before the FDA can consider an application for approval of the treatment for severe to moderate nasolabial fold wrinkles in adults.
Fibrocell needed to run further tests on the injectable treatment, and said it will undergo a six-month FDA review. The biologics license application for the treatment was originally filed in March 2009.
The company also is seeking FDA approval to explore use of the treatment for acne scarring. - Roslyn Rudolph