Pozen Expects to Submit Revised Response to Trexima(TM) (Sumatriptan/Naproxen Sodium) Approvable Letter by Year End
Press Release Source: POZEN Inc.
Pozen Expects to Submit Revised Response to Trexima(TM) (Sumatriptan/Naproxen Sodium) Approvable Letter by Year End
Wednesday December 13, 7:00 am ET
CHAPEL HILL, N.C.--(BUSINESS WIRE)--POZEN Inc. (NASDAQ: POZN - News) 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(TM) 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."
Webcast
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.
Pozen Expects to Submit Revised Response to Trexima(TM) (Sumatriptan/Naproxen Sodium) Approvable Letter by Year End
Wednesday December 13, 7:00 am ET
CHAPEL HILL, N.C.--(BUSINESS WIRE)--POZEN Inc. (NASDAQ: POZN - News) 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(TM) 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."
Webcast
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.
posted by B at 7:48 PM
0 Comments:
Post a Comment
<< Home