Qnexa Approval

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Qnexa®, now re-branded as Qsymia®, is a weight loss and obesity drug that was approved by the Food and Drug Administration on July 16, 2012. Upon approval, it was announced that the medication would be sold under the new name Qsymia®. The name change is due to the name Qnexa® sounding similar to other medications. Qsymia® is FDA-approved for the treatment of obese people who have at least one health problem that is weight related. This includes Type 2 diabetes, high blood pressure, and high cholesterol.[1]

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cestari
Flickr: klf_blf
Brand name for Combination of topiramate with phentermine[2]
Manufacturer Vivus, Inc.[2]
Phone number 650-934-5200[3]
Uses Treats obesity[2]
FDA approval July 16, 2012
Disclaimer The information provided by PharmacyDrugGuide is not a substitute for professional medical advice, diagnosis, or treatment. Do not take any action based on the information on this page without consulting a physician.
Author Susan MacDowell;
 
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Contents

Qsymia FDA Approval Process

  • December 28, 2009: Vivius submits a New Drug Application (NDA, seeking approval to market Qsymia® in the United States[4]
  • March 1, 2010: FDA accepted the NDA[4]
  • July 13, 2010: FDA review released
  • July 15, 2010: FDA Advisory Committee recommends rejection[4]
  • October 28, 2010: FDA rejects Qsymia®[5]
  • October 2011: Vivius resubmits NDA
  • November 2011: FDA accepts NDA
  • February 22, 2012: FDA advisory panel votes 20-2 that harmful Qsymia® side effects are outweighed by its benefits
  • July 15, 2012: PDUFA target date[6]
  • July 16, 2012: Qsymia® is approved by the FDA

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Qsymia (Qnexa) on Fox Charlotte News

Fox Charlotte news report on weight loss drugs

About Qsymia

Vivus states that Qsymia® (phentermine and topiramate) was designed to address both "appetite and satiety" to combat obesity. Phentermine has been marketed since 1959, and is the most-prescribed prescription weight loss medication in the United States. It is sold under the brand name Adipex®, among others. Topiramate was approved in 1996, and is usually prescribed to treat epilepsy and prevent migraine headaches.[7]

Common side effects associated with Qsymia® include difficulty sleeping, tingling in the feet and hands, constipation, dizziness, and dry mouth.[1]

Research has shown that Qsymia® users lose an average of 14 percent of their body weight in the first year, and about 10 percent of their body weight over the first two years. Trials also showed that Qsymia® users had lower cholesterol levels and reduced incidence of diabetes.[7]

On July 13, 2010, the FDA released background documents in preparation for the Qsymia® FDA Advisory committee meeting scheduled for July 15. In the report, the FDA concluded that Qsymia® was effective for weight loss, but that there were several areas of safety concerns. The FDA was concerned about Qsymia®'s effect on pregnant women and the possibility that Qsymia® could cause psychiatric side effects such as depression and thoughts of suicide.[8] Other Qsymia® side effects mentioned in the report included problems with attention span, memory and language issues, and reports of increased heart rate in Qsymia® patients.[9]

Qsymia®'s July 2012 approval was the second new obesity treatment medication approved in a period of 30 days. Prior to that, no new obesity drug had been approved in 10 years.[1]


Also See: Qnexa Side Effects, Lorcaserin Approval, Contrave Approval, Diet Pills, Green Tea Diet Pills, Diet Pill Side Effects, Acai Diet Pills, Hoodia Diet Pills, Drug Side Effects, Quick Trim

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References

  1. 1.0 1.1 1.2 http://www.cbsnews.com/8301-504763_162-57474619-10391704/obesity-pill-qsymia-gains-fda-approval/
  2. 2.0 2.1 2.2 http://www.vivus.com/pipeline/qnexa-obesity
  3. http://www.vivus.com/contact
  4. 4.0 4.1 4.2 http://www.fiercebiotech.com/press-releases/vivus-announces-date-fda-advisory-committee-review-qnexa-r-treatment-obesity
  5. http://www.examiner.com/fda-in-national/fda-rejects-approval-of-obesity-drug-qnexa
  6. http://regulatoryaffairs.pharmaceutical-business-review.com/news/vivus-qnexa-secures-fda-approval-for-nda-filing-041111
  7. 7.0 7.1 http://articles.latimes.com/2011/dec/09/news/la-heb-weight-loss-drug-20111209
  8. http://www.msnbc.msn.com/id/39905030/ns/health-diet_and_nutrition/
  9. http://www.msnbc.msn.com/id/38152052/ns/us_news/