Skip to Content

Sculptra Approval History

  • FDA approved: Yes (First approved August 3rd, 2004)
  • Brand name: Sculptra
  • Generic name: injectable poly-L-lactic acid
  • Company: Sanofi-aventis U.S.
  • Treatment for: Facial Lipoatrophy; Facial Wrinkles

Sculptra (injectable poly-L-lactic acid) is a dermal filler indicated for the restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus. Sculptra Aesthetic is indicated for the correction of shallow to deep nasolabial fold (smile lines) contour deficiencies and other facial wrinkles in healthy patients.

Development History and FDA Approval Process for Sculptra

Jul 29, 2009Approval FDA Approves Sculptra Aesthetic, a Facial Injectable for Correction of Nasolabial Folds and Other Facial Wrinkles
Aug  3, 2004Approval Sculptra Dermik Laboratories - Treatment for Facial Lipoatrophy in HIV Patients
Mar 26, 2004Sculptra From Dermik Laboratories Receives Recommendation For Approval With Conditions From FDA Advisory Panel
Feb  6, 2004Aventis' Dermik Laboratories Announces FDA Acceptance of Filing For Sculptra to Treat Facial Lipoatrophy

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.