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FDA posts Meridia briefing documents

September 14, 2010 12:47 AM UTC

FDA posted briefing documents ahead of Wednesday's meeting of the Endocrinologic and Metabolic Drugs Advisory Committee to discuss cardiovascular safety signals seen in the long-term Phase III SCOUT trial of anti-obesity drug Meridia sibutramine from Abbott Laboratories (NYSE:ABT).

At the meeting, panelists will be asked to recommend if FDA should allow continued marketing of Meridia with or without a boxed warning concerning increased risk of major adverse cardiac events (MACE), continued marketing with both a boxed warning and restricted distribution, or if the drug should be withdrawn from the U.S. market. ...