FDA to discuss Lotronex's REMS

FDA's Drug Safety and Risk Management Advisory Committee will meet on July 10 to discuss the Lotronex alosetron from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and partner Prometheus Laboratories Inc., a unit of Nestle S.A. (SIX:NESN). Lotronex's ETASU require healthcare providers to be specially certified and enrolled in a prescribing program. Additionally, patients must sign a form acknowledging the risks of the product, and pharmacists can only fill paper prescriptions bearing a sticker showing the prescriber is certified in the program. The committee will discuss whether the REMS with ETASU assures safe use, is not unduly burdensome to patient access and minimizes burden to the health care delivery system. ...