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Orexigen Eyes Earlier Resubmission Of Contrave NDA

 
• By Sue Sutter

The company is optimistic it can work out an agreement with FDA to re-file the obesity drug application before it has interim data from a cardiovascular outcomes trial in hand.

Although Orexigen Therapeutics Inc. failed in its latest bid to persuade FDA’s Center for Drug Evaluation and Research to consider approving Contrave (naltrexone/bupropion) before results come in from a dedicated cardiovascular outcomes study, the company believes the response received from the agency puts it on a path to a speedier NDA resubmission for the obesity agent.

Orexigen acknowledges that procedural details for an earlier resubmission need to be worked out with the agency. Nevertheless, the company...

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