Sculptra – P030050/S039
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 Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: Sculptra
PMA Applicant: Q-Med AB
Address: Seminariegatan 21, SE-752 28 Uppsala, Sweden
Approval Date: April 25, 2023
Approval Letter: Approval Order
What is it?
Sculptra is a gel implant or dermal filler that is injected into specific areas of facial tissue. It consists of the chemicals poly-L-lactic acid (PLLA), carboxymethylcellulose, and non-pyrogenic mannitol. Sculptra is reconstituted before use by adding sterile water for injection to form a suspension. A solution of the drug lidocaine hydrochloride can be added just before use to reduce pain on injection.
This approval expands the use of this product to include use for correction of fine lines and wrinkles in the cheek region of people whose bodies are able to produce a normal immune response (immune-competent).
How does it work?
A doctor injects Sculptra under the skin (subcutaneous) to fill in fine lines and wrinkles in the skin, including on the cheeks.
When is it used?
This new approval establishes the use of Sculptra for correction of fine lines and wrinkles in the cheek region for people who are immune-competent.
What will it accomplish?
Sculptra may improve the appearance of fine lines and wrinkles in the cheeks. In a clinical study, patients received up to four injections to achieve the best outcome. The results may last up to 24 months.
When should it not be used?
Sculptra should not be used for people who have:
- Hypersensitivity to any of its components.
- Severe allergies with a history of anaphylaxis.
- A history or known presence of multiple severe allergies.
- Known history or susceptibility to raised firm scars, including keloids or hypertrophic scarring.
- A history of allergy to lidocaine or other amide-type local anesthetics (when Sculptra is reconstituted with lidocaine).