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Regulatory Update For Qnexa Could Signal A Change In The Obesity Landscape

This article was originally published in The Pink Sheet Daily

Executive Summary

New developments for Vivus’ weight loss drug Qnexa may mean that the regulatory environment for obesity treatments could be improving.

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Qnexa REMS Should Deter Off-Label Use Of Components, But Not Place Undue Burden

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.

FDA Says Qnexa Needs CV Outcome Trial, Asks Cmte. To Consider Pre- Or Post-Approval Timeframe

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.

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 New analysis of SCOUT data for Abbott’s withdrawn Meridia (sibutramine) could crop up in the discussion, former panelist says.

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