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

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.

Those who want to speak at the hearing should notify the FDA before March 15.

For more information on the logistics, visit 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 www.fda.gov/cdrh/panelmtg.html.

ISSN # 1052-4207

Copyright 2004 by John S. James. Permission granted for noncommercial reproduction, provided that our address and phone number are included if more than short quotations are used.