The uncertainty that has plagued obesity drugs submitted for approval in a difficult-to-predict regulatory environment could soon be cleared up. FDA’s Endocrinologic and Metabolics Drugs Advisory Committee is set to meet March 28-29 to discuss cardiovascular assessment of obesity drugs before and after approval.
Advisory Committee Set To Review Cardiovascular Risk Assessment For Obesity Drugs
Recent guidance on Orexigen’s Contrave could provide clues about how the agency is leaning on drugs in the highly safety conscious obesity category. New analysis of SCOUT data for Abbott’s withdrawn Meridia (sibutramine) could crop up in the discussion, former panelist says.
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