Submission Type: BLA Submission ID: 125348/0 Office: OCTGT
Autologous Cultured Fibroblasts
Fibrocell Technologies, Inc.
Telecon Date/Time: 26-Aug-2009 02:00 PM Initiated by FDA? Yes
Author: LORI TULL
Discussion regarding indication statement
FDA Participants: Changting Haudenschild, Agnes Lim, Bruce Schneider, Lori Tull
Non-FDA Participants: Jeanne Novak, Jessica Allmond, David Hines
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
FDA suggested a change in the indication from treatment to “indicated for the temporary improvement of moderate to severe nasolabial fold wrinkles”. Isolagen responded that there was the potential for long term improvement and “temporary” would be contrary to their data. FDA stated that only 6 months of efficacy data was available. Isolagen replied that they understood, but the intention of the treatment was long-term. Isolagen requested that “for at least 6 months” or “up to 6 months” be used. FDA responded that they would discuss the issue internally and get back to Isolagen.