FDA warns against second attempts at weight loss drug approvals

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FDA warns against second attempts at weight loss drug approvals

Post by Tee on Sat Mar 03, 2012 9:19 pm

This has always concerned me - giving Topamax for weight control....what do you think?


The State Column | Saturday, February 18, 2012

The U.S. Food and Drug Administration (FDA) continues to share concerns regarding the safety of experimental diet pills produced by Vivus Inc. This company is one of three drug companies that are preparing for drug’s safety approval. In the case of Vivus Inc., this is their second attempt for drug safety approval for Qnexa.

There have been no new prescription weight loss drug to enter the market in over a decade, and drug companies are racing to have their new weight loss drug hit the market first. Arena Pharmaceuticals Inc., Orexigen Therapeutics Inc. and Vivus have submitted weight loss drugs for FDA approval with no success. All three companies are currently preparing for resubmitting their drug products for approval.

Most recently, Vivus Inc. has announced they are preparing their weight loss drug for a second attempt for FDA approval. In the past, the drug posed safety risks, including heart risk and birth defects, according to the FDA. However, these side effects have not been reported in their follow-up study.



Read more: http://www.thestatecolumn.com/articles/2012/02/18/fda-continues-warnings-over-new-diet-pills/#ixzz1o31VQKWb

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