Treximet FDA Approval History
FDA Approved: Yes (First approved April 15, 2008)
Brand name: Treximet
Generic name: sumatriptan succinate and naproxen sodium
Dosage form: Tablets
Previous Name: Trexima
Company: Currax Pharmaceuticals LLC
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.
Development timeline for Treximet
Date | Article |
---|
May 15, 2015 | Approval FDA Approves Treximet (sumatriptan and naproxen sodium) for Migraine in Pediatric Patients |
Apr 16, 2008 | Approval Treximet (sumatriptan and naproxen sodium) Tablets Approved by FDAfor Acute Treatment of Migraine |
Jan 16, 2008 | Pozen Submits Human Lymphocyte Study for Treximet (Formerly Known
as Trexima) |
Nov 1, 2007 | Pozen Announces Trexima (Sumatriptan Succinate and Naproxen Sodium)
Amended Response Accepted for Review by FDA |
Oct 15, 2007 | Pozen Submits Response to Approvable Letter for Trexima |
Oct 5, 2007 | Pozen Plans to Submit Response to Approvable Letter For Trexima
Within the Next Ten Days |
Aug 2, 2007 | FDA Issues Second Approvable Letter for Trexima |
Mar 22, 2007 | Pozen Announces Trexima (Sumatriptan Succinate and Naproxen Sodium) Amended Response Accepted for Review by FDA |
Dec 13, 2006 | Pozen Expects to Submit Revised Response to Trexima Approvable Letter by Year End |
Nov 9, 2006 | Pozen Submits Full Response to FDA Approvable Letter For Trexima |
Jul 31, 2006 | Pozen to Submit Full Response to Trexima Approvable Letter During the Fourth Quarter |
Jun 9, 2006 | Pozen Inc. and GlaxoSmithKline Report Receipt of Approvable Letter for Investigational Migraine Treatment |
Oct 11, 2005 | GlaxoSmithKline and POZEN Announce Trexima (Sumatriptan Succinate and Naproxen Sodium) New Drug Application Accepted for Review by FDA |
Aug 8, 2005 | POZEN Submits New Drug Application for Trexima (Sumatriptan Succinate and Naproxen Sodium) for the Acute Treatment of Migraine |
Further information
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