3/26/2004

An FDA panel gave its blessing to Aventis' Sculptra injection for treating a byproduct of HIV, likely leading to eventual agency approval for the drug, the first for filling in sunken facial features. Panel members said the drug, already approved in Europe as New-Fill, has shown convincing evidence of safety and effectiveness, although some FDA panel members raised concerns about the lack of testing on large numbers of women and minorities and about the drug's possible off-label cosmetic applications.

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