Sanofi-Aventis U.S. LLC’s Dermik Laboratories Submitted USFDA Supplemental Premarket Approval Application (s-PMA) for Sculptra®
The dermatology business of sanofi-aventis U.S. LLC, Dermik Laboratories, has recently submitted a supplemental premarket approval application (s-PMA) to the USFDA for Sculptra® (injectable poly-L-lactic acid) for facial cosmetic use.
Sculptra®, sold under the trade name NEW-FILL™, was approved in
Sculptra®, a synthetic, biocompatible, bioabsorbable material that is naturally degraded by the body over time, was approved in the in 2004 for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus.
Source: PR Newswire
