Leprosy

FDA Panel Recommends Licensing Thalidomide

Published in AIDS Weekly, September 22nd, 1997

A government advisory panel voted to recommend approval of thalidomide, a drug notorious for causing birth defects but which offers dramatic cures for diseases ranging from leprosy to AIDS.

The U.S. Food and Drug Administration (FDA) advisory committee heard two days of testimony about the safety and efficacy of Celgene Corp's version of the drug, known as Synovir, in treating a painful side-effect of leprosy known as erythema nodosum leprosum (ENL).

In an unusual move, the panel advised licensing of all versions of the drug, not just Celgene's formulation. But, mindful of testimony from patients of thalidomide, they recommended severely restricting...

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Source: AIDS Weekly (1997-09-22)

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