Qsymia Approval History

  • FDA approved: Yes (First approved July 17th, 2012)
  • Brand name: Qsymia
  • Generic name: phentermine and topiramate
  • Previous name: Qnexa
  • Company: Vivus, Inc.
  • Treatment for: Obesity

Qsymia (phentermine and topiramate) is a combination of phentermine, a sympathomimetic amine anorectic, and topiramate extended-release, an antiepileptic drug, indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults.

FDA Approval History for Qsymia

DateArticle
Jul 17, 2012Approval FDA Approves Weight-Management Drug Qsymia
Apr 10, 2012Vivus Receives Notification of Qnexa PDUFA Date Extension
Feb 23, 2012FDA Advisory Committee Recommends Approval of Qnexa
Jan  9, 2012VIVUS Provides Qnexa Regulatory Update
Dec 27, 2011VIVUS Announces Date of FDA Advisory Committee Review of Qnexa for the Treatment of Obesity
Nov  3, 2011FDA Accepts New Drug Application Filing for Qnexa
Oct 17, 2011VIVUS Resubmits Qnexa NDA to the FDA
Jan 21, 2011VIVUS Provides Regulatory Update on Qnexa NDA
Dec 14, 2010VIVUS Submits Briefing Document to FDA, Announces Follow-up Meeting to Discuss QNEXA
Oct 29, 2010FDA Issues Complete Response Letter to Vivus Regarding New Drug Application for Qnexa
Jul 16, 2010Vivus Comments on FDA Advisory Committee Panel Meeting on Qnexa (phentermine/topiramate) Controlled Release Capsules for the Treatment of Obesity
Mar 26, 2010VIVUS Announces Date of FDA Advisory Committee Review of Qnexa for the Treatment of Obesity
Mar  2, 2010VIVUS Announces FDA Acceptance of Qnexa New Drug Application for Treatment of Obesity
Dec 29, 2009Vivus Submits Qnexa New Drug Application to the 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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