TreximetTreatment for Migraine
Update: Treximet Now FDA Approved - April 15, 2008
Pozen to Submit Full Response to Trexima Approvable Letter During the Fourth Quarter
CHAPEL HILL, N.C., July 31, 2006 - POZEN Inc. announced today that they plan to submit a full response to the Approvable letter for Trexima during the fourth quarter of 2006. The full response will include additional safety information. This action comes after POZEN and GlaxoSmithKline met jointly with the U.S. Food and Drug Administration (FDA) to discuss and reach agreement on the proposed plan for responding to the Approvable letter. The FDA will have up to six-months to review the information contained in the full response.
Dr. John R. Plachetka, POZEN's chairman, president and chief executive officer stated, "We are very pleased to reach agreement with the FDA allowing us to make a full response in a timely manner."
Trexima is the proposed brand name for the combination of sumatriptan succinate, formulated with RT Technology(TM), and naproxen sodium, in a single tablet for the acute treatment of migraine.
Posted: July 2006
- Treximet (sumatriptan and naproxen sodium) Tablets Approved by FDA for Acute Treatment of Migraine - April 16, 2008
- Pozen Submits Human Lymphocyte Study for Treximet (Formerly Known as Trexima) - January 16, 2008
- Pozen Announces Trexima (Sumatriptan Succinate and Naproxen Sodium) Amended Response Accepted for Review by FDA - November 1, 2007
- Pozen Submits Response to Approvable Letter for Trexima - October 15, 2007
- Pozen Plans to Submit Response to Approvable Letter For Trexima Within the Next Ten Days - October 5, 2007
- FDA Issues Second Approvable Letter for Trexima - August 2, 2007
- Pozen Announces Trexima (Sumatriptan Succinate and Naproxen Sodium) Amended Response Accepted for Review by FDA - March 22, 2007
- Pozen Expects to Submit Revised Response to Trexima Approvable Letter by Year End - December 13, 2006
- Pozen Submits Full Response to FDA Approvable Letter For Trexima - November 9, 2006
- Pozen Inc. and GlaxoSmithKline Report Receipt of Approvable Letter for Investigational Migraine Treatment - June 9, 2006
- GlaxoSmithKline and POZEN Announce Trexima (Sumatriptan Succinate and Naproxen Sodium) New Drug Application Accepted for Review by FDA - October 11, 2005
- POZEN Submits New Drug Application for Trexima (Sumatriptan Succinate and Naproxen Sodium) for the Acute Treatment of Migraine - August 8, 2005