FDA Poised to OK Sale of Thalidomide
From Times Staff and Wire Reports
The Food and Drug Administration says it is poised to approve the sale of thalidomide, once the world’s most infamous drug. The FDA informed Celgene Corp. in a letter that thalidomide would be approved to treat an agonizing inflammation in leprosy patients--once the company meets some final conditions, including tight restrictions aimed at avoiding the birth-defect horrors of the 1960s. Thalidomide was banned worldwide 35 years ago after it caused horrific birth defects in 12,000 babies. It had been sold as a sedative for pregnant women in 48 countries--but never in the United States.
