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Advisory committee to evaluate FDA's orlistat review

This article was originally published in The Tan Sheet

Executive Summary

The Pediatric Advisory Committee's March 22 meeting 1agenda includes a "brief follow-up" on FDA's August 2009 "early communication" letter concerning orlistat, the active ingredient in the OTC weight-loss drug alli (60 mg) and Rx Xenical (120 mg). FDA received 32 reports of serious liver injury in patients taking orlistat between 1999, when it first approved Xenical, and 2008; FDA approved alli in 2007 (2"The Tan Sheet" Aug. 31, 2009). The meeting in Bethesda, Md., will include safety reviews on oral and topical drugs for children. FDA will accept written submissions for the meeting through March 8. Oral presentations from the public are scheduled for 1 p.m. to 2 p.m. Requests to make presentations are due by Feb. 28


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