Xenical Switch Proposal Slated For Advisory Committee Review In January
This article was originally published in The Pink Sheet Daily
FDA’s Nonprescription Drugs and Endocrinologic & Metabolic Drugs advisory committees will meet Jan. 23 to review GSK’s application for over-the-counter use of 60 mg orlistat.
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GlaxoSmithKline has proposed to market over-the-counter orlistat under the trade name Alli.
Compliance consultants warn that certain dietary supplement good manufacturing practices violations are inspection "showstoppers" and will draw agency enforcement