TreximetTreatment for Migraine
Update: Treximet Now FDA Approved - April 15, 2008
Pozen Expects to Submit Revised Response to Trexima Approvable Letter by Year End
CHAPEL HILL, N.C., December 13, 2006 - POZEN Inc. announced today that the U.S. Food and Drug Administration (FDA) has completed its initial review of POZEN's response to the June 8, 2006 Approvable Letter for Trexima and has determined the response is not yet complete. The FDA has requested additional analyses and supporting information relating to the data submitted in the November response.
Provision of the additional information will allow the FDA to determine the comparability of the new data submitted in November to that contained within the original Trexima NDA and to more fully assess the relative safety profile of Trexima. POZEN expects to prepare and submit the revised response before year end.
Dr. Marshall Reese, executive vice president, product development of POZEN stated, "We appreciate this additional guidance from the FDA with respect to the information to be included in our complete response. Although there is no certainty that these revisions, coupled with the original data, will lead to the approval of the Trexima NDA, we continue to believe that the data for Trexima demonstrate superior efficacy and a safety profile comparable to sumatriptan."
POZEN will hold a webcast to provide an overview on the Trexima full response clarification on Wednesday, December 13, 2006 at 8:30 a.m. Eastern Time. The call-in number for the webcast is 877-385-2370 (domestic) and 706-679-0866 (international). The access code is 4434183. A replay will be available beginning at 1:30 p.m. on Wednesday, December 13, 2006, and may be accessed by dialing 800-642-1687 (domestic) or 706-645-9291 (international) and entering the conference call code 4434183. The webcast can be accessed live and will be available for replay at www.pozen.com.
Source: POZEN Inc.
Posted: December 2006
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- 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 Submits Full Response to FDA Approvable Letter For Trexima - November 9, 2006
- Pozen to Submit Full Response to Trexima Approvable Letter During the Fourth Quarter - July 31, 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