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Qsymia Approval History

  • FDA approved: Yes (First approved July 17th, 2012)
  • Brand name: Qsymia
  • Generic name: phentermine and topiramate
  • Dosage form: Extended-Release Capsules
  • 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.

Development History and FDA Approval Process for Qsymia

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

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