BioCentury
ARTICLE | Company News

FDA refuses to provide guidance on shared REMS

October 21, 2013 11:39 PM UTC

FDA denied a Citizen's Petition from Prometheus Laboratories Inc. asking the agency to provide guidance on how to develop a single, shared REMS. Prometheus filed the petition in June. The company is in discussions to develop a shared REMS for irritable bowel syndrome drug Lotronex alosetron with generic company Roxane Laboratories Inc., part of Boehringer Ingelheim GmbH (Ingelheim, Germany). FDA also denied Prometheus' request for the agency to notify the company of waiver requests for the requirement for Lotronex's shared REMS (see BioCentury Extra, June 6).

Lotronex was withdrawn from the market in 2000 following reports of ischemic colitis and serious constipation complications. The drug was reapproved with new restrictions in 2002 and has a REMS with elements of safe use (ETASU). In July, FDA's Drug Safety and Risk Management Advisory Committee recommended modifying the REMS for Lotronex to ease the burden on pharmacists (see BioCentury Extra, July 10). ...