Sculptra FDA Approval

asked 2 years ago by thenightmarethatdoesn'tquit in LA
Latest answer by Nathan Mayl, MD
Question viewed 484 times
Tags: FDA

What has the US FDA Approved for Sculptra Use

5 answers to Sculptra FDA Approval

Sculptura approved for cosmetic

Thanks for your question, Yes it is true the FDA just gave approval for Sculptura. The previous indication was for facial wasting for patients with HIV. It has been a safe and effective treatment for sometime. Many physicians have been using it "off label" for sometime. At our San Francisco area office we're using it for people who have experience with other fillers and like the results and want a longer lasting result. I hope this helps.

Steven H. Williams, MD
San Francisco Plastic Surgeon

Sculptra approval has been extended to cosmetic uses in addition to HIV facial atrophy

As most physicians who picked up Sculptra early, we have been using it off label in cosmetic patients since it originally was approved. It is a great product for properly selected patients who are not in a hurry to see their results. It is a "stimulatory" filler so that the built up develops slowly and usually takes several sessions. However it has the longest durability of any "non-permanent" filler.

Nathan Mayl, MD
Fort Lauderdale Plastic Surgeon

Sculptra approval by FDA

Sculptra Aesthetic was approved by the FDA on July 29th, 2009 for use in correcting shallow or deep nasolabial fold contour deficiencies as well as other facial wrinkles. Sculptra is one of the most advanced treatments for restoring depleted volume to areas such as the cheeks, jowls, and nasolabial fold regions. Sculptra Aesthetic differs significantly from traditional fillers, such as Juvederm, Radiesse, and Restylane. The duration of effect is at least 2 years, and possibly much longer.... more

Brian S. Glatt, MD
Morristown Plastic Surgeon

Is Sculpta FDA approved?

Sculptra has been FDA approved in the US since 2004 as treatment for facial fat loss in HIV patients (facial lipo-dystrophy). However, Sculptra has been used by physicians for non-FDA indications such as cosmetic treatment of facial wrinkles or volume loss in non- HIV patients. This is known as an off-label use of the drug. There are many other instances of off-label use of drugs, such as injection of Cosmetic Botox into crow's feet area. (Cosmetic Botox is only FDA approved for use in the... more

Maurice M. Khosh, MD
New York Facial Plastic Surgeon

Sculptra just approved for Facial Cosmetic use

Yes, it is correct. Two days ago FDA approved Sculptra for cosmetic use on the face. It has been approved since 1999 for use in HIV individuals who lose fat in the face as a result of the anti retroviral therapy leading to sunken cheeks and temples. We i.e., the physicians have been using it off label for cosmetic reasons as well. It works very well but you have to be trained before using Sculptra. Regards

Tanveer Janjua, MD
Bedminster Facial Plastic Surgeon

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