Sculptra - P030050
This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: Sculptra
Applicant: Dermik Laboratories
Address: 1050 Westlakes Drive, Berwyn, PA 19312
Approval Date: August 3, 2004
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf3/p030050a.pdf
What is it? Sculptra is an injectable poly-L-lactic acid implant in the form of a sterile, freeze-dried preparation. Sculptra contains microparticles of poly-L-lactic acid, a biodegradable, biocompatible synthetic polymer from the alpha-hydroxy-acid family.
How does it work? Sculptra works by temporarily adding volume to facial tissue and restoring a smoother, fuller appearance to the face. After the initial treatment series, repeat treatments may be needed to maintain the effect. The effect lasts for about one year.
When is it used? Sculptra is injected by a doctor into areas of facial fat loss (facial lipoatrophy) in patients with, or receiving treatment for, Human Immunodeficiency Virus (HIV).
What will it accomplish? Sculptra will restore shape and contour deficiencies in areas of facial lipoatrophy. The implant temporarily adds volume to the face and can give the appearance of a smoother, fuller face.
Side effects of Sculptra include:
- raised bumps of skin (nodules),
- pain, and
When should it not be used? Sculptra should not be used in patients who have a hypersensitivity to any of the components of the implant.
Additional information: Summary of Safety and Effectiveness and labeling is available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p030050