Regulatory Focus™ > News Articles > Obesity Drug Gets FDA Panel Support

Obesity Drug Gets FDA Panel Support

Posted 23 February 2012 | By

Advisors to the Food and Drug Administration (FDA) have recommended the obesity drug Qnexa for approval, according to a report by Pharma Times Online.

The prescription diet drug manufactured by Vivus is on track to be the first to reach the US market since 1999. The Endocrinologic and Metabolic Drugs Advisory Committee voted 20-2 in favor of the drug, stating the benefits outweigh the risks.

Pharma Times Online reported that the panel stressed to the company that it should conduct post-market studies for potential cardiovascular side effects.

Vivus plans to train prescribers and distribute warning pamphlets if Qnexa gets approval. A final decision by FDA is expected around 17 April.

Read more:
Pharma Times Online: FDA panel backs Vivus obesity drug Qnexa

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