Contrave Diet Pill FDA Decision Expected on Monday
The Contrave(R)diet pill being developed by Orexigen, Inc. will discover it's fate tomorrow when the FDA decides whether or not to approve the drug. In December, an FDA advisory committee voted to recommend Contrave(R) for approval.
The panel was split and they also noted that some further research is needed which in their opinion could be done once approval has taken place. During the recent past, the FDA has denied approval for a couple of new drugs and recommended that another weight loss drug be removed from the market, so it is far from a sure thing that Contrave(R) will make it on this try.
The FDA could deny the application outright, but this is less likely due to the committee approval. They could decide that the research needs to be completed prior to approval, which would send Orexigen back to the drawing board setting up some new trials. Finally they could approve Contrave(R) and allow the needed research to be done afterwards. This would be the easier way for Orexigen, since once it's on the market, there will be thousands of users available to get the required data from.
Approval here may also pave the way for Orexigen's other weight loss drug, Empatic(TM), which like Contrave(R) is a combination of two drugs which are already sold on the market for other things.
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The panel was split and they also noted that some further research is needed which in their opinion could be done once approval has taken place. During the recent past, the FDA has denied approval for a couple of new drugs and recommended that another weight loss drug be removed from the market, so it is far from a sure thing that Contrave(R) will make it on this try.
The FDA could deny the application outright, but this is less likely due to the committee approval. They could decide that the research needs to be completed prior to approval, which would send Orexigen back to the drawing board setting up some new trials. Finally they could approve Contrave(R) and allow the needed research to be done afterwards. This would be the easier way for Orexigen, since once it's on the market, there will be thousands of users available to get the required data from.
Approval here may also pave the way for Orexigen's other weight loss drug, Empatic(TM), which like Contrave(R) is a combination of two drugs which are already sold on the market for other things.
Technorati Tags: Contrave™ naltrexone Diet Pills Weight Loss Pillsbupropion Diet Weight Loss Losing WeightEmpaticFDA
Labels: contrave, diet pill, empatic, fda, food and drug administration, losing weight, orexigen, weight loss, weight loss pills

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