Treximet Approval History

  • FDA approved: Yes (First approved April 15th, 2008)
  • Brand name: Treximet
  • Generic name: sumatriptan succinate and naproxen sodium
  • Previous name: Trexima
  • Company: Pozen Inc.
  • Treatment for: Migraine

Treximet is a combination of sumatriptan (a migraine-specific triptan) and naproxen (an anti-inflammatory pain reliever) in a single tablet for the acute treatment of migraine.

FDA Approval History for Treximet

DateArticle
Apr 16, 2008Approval Treximet (sumatriptan and naproxen sodium) Tablets Approved by FDA for Acute Treatment of Migraine
Jan 16, 2008Pozen Submits Human Lymphocyte Study for Treximet (Formerly Known as Trexima)
Nov  1, 2007Pozen Announces Trexima (Sumatriptan Succinate and Naproxen Sodium) Amended Response Accepted for Review by FDA
Oct 15, 2007Pozen Submits Response to Approvable Letter for Trexima
Oct  5, 2007Pozen Plans to Submit Response to Approvable Letter For Trexima Within the Next Ten Days
Aug  2, 2007FDA Issues Second Approvable Letter for Trexima
Mar 22, 2007Pozen Announces Trexima (Sumatriptan Succinate and Naproxen Sodium) Amended Response Accepted for Review by FDA
Dec 13, 2006Pozen Expects to Submit Revised Response to Trexima Approvable Letter by Year End
Nov  9, 2006Pozen Submits Full Response to FDA Approvable Letter For Trexima
Jul 31, 2006Pozen to Submit Full Response to Trexima Approvable Letter During the Fourth Quarter
Jun  9, 2006Pozen Inc. and GlaxoSmithKline Report Receipt of Approvable Letter for Investigational Migraine Treatment
Oct 11, 2005GlaxoSmithKline and POZEN Announce Trexima (Sumatriptan Succinate and Naproxen Sodium) New Drug Application Accepted for Review by FDA
Aug  8, 2005POZEN Submits New Drug Application for Trexima (Sumatriptan Succinate and Naproxen Sodium) for the Acute Treatment of Migraine

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.

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