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Sculptra Approval History

FDA Approved: Yes (First approved August 3, 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

DateArticle
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

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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