Treximet
sumatriptan succinate and naproxen sodium
Treatment for MigrainePozen 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.
Source: POZEN
Related Articles:
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
New Drug Applications Archive
2007: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2006: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2005: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2004: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
