FDA Says Qnexa Needs CV Outcome Trial, Asks Cmte. To Consider Pre- Or Post-Approval Timeframe
This article was originally published in The Pink Sheet Daily
Endocrinologic and Metabolic Drugs Advisory Committee also will weigh in on a teratogenicity risk management strategy for Vivus’ weight-loss drug during a Feb. 22 meeting.
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The Endocrinologic and Metabolic Drugs Advisory Committee voted 20-2 in favor of approving the combination of phentermine and topiramate for weight loss during its second review of Vivus’ application.
Office of New Drugs Director John Jenkins reassured panel members of the agency’s ability to assess civil penalties or cite a drug for misbranding if sponsors fail to meet post-market study obligations.
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 New analysis of SCOUT data for Abbott’s withdrawn Meridia (sibutramine) could crop up in the discussion, former panelist says.