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Contrave FDA Approval History

FDA Approved: Yes (First approved September 10, 2014)
Brand name: Contrave
Generic name: bupropion and naltrexone
Dosage form: Tablets
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.

Development Timeline for Contrave

Sep 10, 2014ApprovalFDA 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

Further information

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