|
|
Article: FDA READY TO OK THALIDOMIDE FOR LEPROSY ACTION CONTINGENT ON TIGHT RESTRICTIONS TO AVOID BIRTH DEFECTS PREVALENT IN 1960S.(News/National/International)
- Article from:
- Rocky Mountain News (Denver, CO)
- Article date:
- September 23, 1997
CopyrightCOPYRIGHT 1997 Rocky Mountain News. All rights reserved. Reproduced with the permission of Dialog LLC by Gale Group. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
|
Byline: Lauran Neergaard Associated Press
WASHINGTON -- The Food and Drug Administration says it is poised to approve the sale of thalidomide, once the world's most infamous drug.
The FDA wrote Celgene Corp. Monday 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.
Celgene said the FDA's ``approvable letter'' contained no surprise conditions, meaning final approval could come ``in weeks rather than months,'' said company spokesman Bob Butler.
Thalidomide was banned ...