Monday, June 10, 2002
The FDA's decision to approve the sNDA for Lotronex alosetron represents the first time the agency has allowed a product back on the market after it was withdrawn for safety reasons. Friday's decision, which was based on an agreement with GlaxoSmithKline plc to implement a comprehensive risk-management program, could set a pattern for future approval of high-risk drugs.
Victor Raczkowski, deputy director of FDA's Office of Drug Evaluation III, told reporters that it was difficult for the FDA to bring the treatment for irritable bowel syndrome back on to the market. "There was a lot of pressure not to do it," he said, but the decision was based on strong demand from patients.