FDA to Consider Reintroduction of GlaxoSmithKline Drug Lotronex




WASHINGTON - The U.S. Food and Drug Administration (FDA) has announced that the advisory committee on gastrointestinal drugs and a newly formed panel on drug safety will meet April 23 to discuss possible "risk management" and reintroduction of the GlaxoSmithKline irritable bowel treatment Lotronex (alosetron hydrochloride).

photo-4GlaxoSmithKline has been lobbying U.S. regulators to allow it to reintroduce Lotronex since January 2001, shortly following the drug's recall the previous November.

"We've received hundreds of calls, letters and e-mails," said GlaxoSmithKline spokeswoman Ramona Dubose. "No other drugs seem to control [the illness] as well for them."

Irritable bowel syndrome causes abdominal …






UPCOMING CONFERENCES




HarrisMartin’s Artificial Stone Silicosis Epidemic Litigation Conference

January 10, 2025 - Long Beach, CA
The Westin Long Beach

MORE DETAILS



HarrisMartin's New Jersey Asbestos Litigation Conference

February 27, 2025 - New Brunswick, NJ
Hyatt Regency New Brunswick

MORE DETAILS