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ARTICLE | Clinical News

Lotronex alosetron hydrochloride regulatory update

May 27, 2013 7:00 AM UTC

FDA's Drug Safety and Risk Management Advisory Committee will meet on July 10 to discuss the REMS with elements of safe use (ETASU) for Lotronex alosetron from GlaxoSmithKline and Nestle's Prometheus Laboratories Inc. unit. 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 that bear 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. ...