FDA Advisory Hearing on New-Fill (Sculptra), March 25, 2004 in Gaithersburg, Maryland

Summary: The FDA will discuss U.S. approval for New-Fill, a facial treatment that Americans have had to go abroad for, although it is approved in Europe and has been used by about 100,000 people worldwide. Those who want to speak at the hearing should notify the FDA by March 15.

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On March 25, 2004 the FDA's General and Plastic Surgery Devices Panel will hold a public hearing on "a premarket approval application (PMA) for an injectable device intended for use in the correction of lipoatrophy of the face in HIV (human immunodeficiency virus) positive patients." AIDS Treatment News has learned that the application is for Sculptra, which is marketed in Europe under the name New-Fill. According to the Web site Drugs.com, it has been used by an estimated 100,000 people worldwide for various facial treatments.

The meeting will be held at the Hilton Washington, DC North, in Gaithersburg, Maryland. Those who want to speak should notify the FDA by March 15.

For more information on the logistics, visit:
http://www.fda.gov/cdrh/panel/index.html

Click on "Upcoming CDRH Advisory Committee/Panel Meetings" then on "Details" for the March 25, 2004 meeting.

Also, background information on this application will be available to the public one day before the meeting, at: http://www.fda.gov/cdrh/panelmtg.html

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