Update on Sculptra (New-Fill) Hearing

Summary: An FDA advisory committee unanimously recommended approval of this facial treatment for people with HIV -- with restrictions to prevent general cosmetic use, pending data to justify such approval.

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On March 25 an FDA advisory panel unanimously recommended that the FDA approve Sculptra (New-Fill) for facial wasting caused by HIV treatment or HIV. They also want restrictions so that it will not be used widely for less urgent purposes like filling wrinkles, unless the company (Dermik Laboratories) comes back with data to support that use. The committee was not happy with the limited amount of data available, but was moved by HIV patients' testimony about their need for the treatment.

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