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

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

See also...

Qsymia (phentermine and topiramate) Consumer Information

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