Artes Medical Inc. Begins Qualification Of U.S. Manufacturing Of ArteFill; Company Takes Significant Next Step Toward Final FDA Approval
10/19/2005 5:10:54 PM
SAN DIEGO--(BUSINESS WIRE)--April 27, 2005--Artes Medical Inc., a privately held specialty pharmaceutical and medical device company, today announced it has begun qualification runs of its flagship product, ArteFill(TM), at its newly completed commercial cGMP manufacturing facility in San Diego. ArteFill is a permanent injectable wrinkle filler used to correct smile lines or naso-labial folds.
These qualification runs of ArteFill are a critical step in the final FDA approval process for Artes Medical. The FDA approvable letter, received by Artes Medical in January 2004, required this milestone to be achieved in order to complete the full FDA approval process.