Contrave Approval Status
- FDA approved: No
- Brand name: Contrave
- Generic name: bupropion and naltrexone
- Company: Orexigen Therapeutics, Inc.
- Treatment for: Obesity
Contrave (bupropion SR/naltrexone SR) is an investigational combination therapy believed to address both behavioral and physiological drivers of obesity.
FDA Approval Status for Contrave
|Jan 7, 2014||Orexigen Announces June 10, 2014 PDUFA Action Date for Contrave|
|Dec 11, 2013||Orexigen Resubmits Contrave New Drug Application|
|Sep 20, 2011||Orexigen and FDA Identify a Clear and Feasible Path to Approval for Contrave|
|Jun 23, 2011||Obesity Groups See Evidence FDA Decisions Will Discourage Obesity Research|
|Jun 3, 2011||Orexigen Therapeutics Provides a Regulatory Update on Contrave NDA|
|Feb 4, 2011||Obesity Society Disappointed by FDA Delay on Approval of Obesity Drug|
|Feb 1, 2011||FDA Issues Complete Response to New Drug Application for Contrave for the Management of Obesity|
|Dec 8, 2010||Orexigen Therapeutics' Investigational Drug Contrave Receives Positive Recommendation from FDA Advisory Committee for Treatment of Obesity|
|Jun 24, 2010||Orexigen Therapeutics Announces Date of FDA Advisory Committee Review of Contrave for the Treatment of Obesity|
|Jun 15, 2010||Orexigen Therapeutics Announces FDA Acceptance of Contrave New Drug Application for the Treatment of Obesity|
|Mar 31, 2010||Orexigen Therapeutics Submits Contrave New Drug Application to FDA for the Treatment of Obesity|
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