Contrave Approval History

  • FDA approved: Yes (First approved September 10th, 2014)
  • Brand name: Contrave
  • Generic name: bupropion and naltrexone
  • Company: Orexigen Therapeutics, Inc.
  • Treatment for: Obesity

Contrave (bupropion/naltrexone) is an aminoketone antidepressant and opioid antagonist combination indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management.

FDA Approval History for Contrave

DateArticle
Sep 10, 2014Approval FDA Approves Contrave (bupropion/naltrexone) for Weight Management
Jan  7, 2014Orexigen Announces June 10, 2014 PDUFA Action Date for Contrave
Dec 11, 2013Orexigen Resubmits Contrave New Drug Application
Sep 20, 2011Orexigen and FDA Identify a Clear and Feasible Path to Approval for Contrave
Jun 23, 2011Obesity Groups See Evidence FDA Decisions Will Discourage Obesity Research
Jun  3, 2011Orexigen Therapeutics Provides a Regulatory Update on Contrave NDA
Feb  4, 2011Obesity Society Disappointed by FDA Delay on Approval of Obesity Drug
Feb  1, 2011FDA Issues Complete Response to New Drug Application for Contrave for the Management of Obesity
Dec  8, 2010Orexigen Therapeutics' Investigational Drug Contrave Receives Positive Recommendation from FDA Advisory Committee for Treatment of Obesity
Jun 24, 2010Orexigen Therapeutics Announces Date of FDA Advisory Committee Review of Contrave for the Treatment of Obesity
Jun 15, 2010Orexigen Therapeutics Announces FDA Acceptance of Contrave New Drug Application for the Treatment of Obesity
Mar 31, 2010Orexigen Therapeutics Submits Contrave New Drug Application to FDA for the Treatment of Obesity

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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