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
|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|
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.