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Qsymia FDA Approval History

Last updated by Judith Stewart, BPharm on June 29, 2022.

FDA Approved: Yes (First approved July 17, 2012)
Brand name: Qsymia
Generic name: phentermine and topiramate
Dosage form: Extended-Release Capsules
Previous Name: Qnexa
Company: Vivus, Inc.
Treatment for: Weight Loss (Obesity/Overweight)

Qsymia (phentermine and topiramate) is a sympathomimetic amine anorectic and anticonvulsant combination for use in chronic weight management.

  • Qsymia is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in:
    • adults with an initial body mass index (BMI) of:
      • 30 kg/m2 or greater (obese) or
      • 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbidity such as hypertension, type 2 diabetes mellitus, or dyslipidemia
    • Pediatric patients aged 12 years and older with BMI in the 95th percentile or greater standardized for age and sex.
  • Phentermine is an amphetamine analogue with anorectic activity that is widely used as an anti-obesity medication. Topiramate is an anticonvulsant that is thought to have an effect on the satiety response and appetite suppression. In combination, these two agents act synergistically to promote weight loss while using lower doses than usually required for each drug alone, in an effort to reduce the adverse side effects of each medication when given at their normal full dose.
  • Qsymia extended-release capsules are taken orally, once daily in the morning.
  • Qsymia warnings and precautions include embryo-fetal toxicity, increased heart rate, suicidal behavior and ideation, increased risk of ophthalmologic adverse reactions, mood and sleep disorders, cognitive impairment, slowing of linear growth, metabolic acidosis, decrease in renal function, and serious skin reactions.
  • Common adverse reactions in adults include paraesthesia, dizziness, dysgeusia, insomnia, constipation, and dry mouth.
  • Common adverse reactions in pediatric patients aged 12 years and older include depression, dizziness, arthralgia, pyrexia, influenza, and ligament sprain.

Development timeline for Qsymia

Jun 27, 2022Approval FDA Approves Qsymia for Chronic Weight Management in Certain Pediatric Patients Aged 12 years and Older
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

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.