Trials & Filings

Orexigen’s Contrave Gets PDUFA Date

Interim CV outcomes study provides "complete response"

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Orexigen Therapeutics has reported that the FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 10, 2014 for the companys recent resubmission of the Contrave (naltrexone sustained release (SR)/bupropion SR) NDA. The move indicates that the agency considers the NDA to be a complete response to the FDA’s January 31, 2011 action letter. Orexigen resubmitted the Contrave NDA in December 2013 following the  announcement of the successful interim analysis of Contrave&#821...

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