Thelin
sitaxsentan
Treatment for Pulmonary Arterial Hypertension (PAH)Encysive Pharmaceuticals Submits Response to FDA For Thelin New Drug Application
HOUSTON, December 14, 2006 -- Encysive Pharmaceuticals today announced it has provided the information requested by the U.S. Food and Drug Administration (FDA) in its letter to the Company dated December 13, 2006 regarding the Company's New Drug Application (NDA) for Thelin (sitaxsentan sodium) 100 mg tablets. This submission is Encysive's response to the FDA's determination that the Company's November 2, 2006 submission was not complete. The FDA is currently evaluating Thelin as a potential new oral treatment for pulmonary arterial hypertension.
If the FDA agrees that today's submission, taken together with the Company's November 2, 2006 submission, represents a complete response, the FDA will establish a new Prescription Drug User Fee Act (PDUFA) action date.
Source: Encysive Pharmaceuticals Inc.
Related Articles:
Encysive Pharmaceuticals Receives Written Response From FDA On Its Request for Formal Dispute Resolution for Thelin (Sitaxsentan Sodium) - September 6, 2007
Encysive Pharmaceuticals Files Request for Formal Dispute Resolution With U.S. FDA to Contest Third Approvable Letter for Thelin - August 7, 2007
Encysive Pharmaceuticals Provides Update for Thelin (Sitaxsentan Sodium) - July 13, 2007
FDA Issues Third Approvable Letter for Thelin (Sitaxsentan Sodium) - June 18, 2007
FDA Accepts Encysive’s Complete Response to Thelin New Drug Application - December 28, 2006
Encysive Expects to Submit Revised Response to Thelin Approvable Letter Within Several Days - December 14, 2006
Encysive Submits Complete Response to FDA For Thelin New Drug Application - November 2, 2006
FDA Issues Approvable Letter for Thelin; One Outstanding Item Remains - July 24, 2006
FDA Grants Class 1 Review to Encysive Pharmaceuticals’ Complete Response to Thelin NDA - June 15, 2006
Encysive Pharmaceuticals Submits Complete Response to FDA for Thelin New Drug Application - May 25, 2006
Encysive Pharmaceuticals Receives Approvable Letter From FDA for Thelin - March 24, 2006
Encysive Announces PDUFA Date for Thelin New Drug Application in Pulmonary Arterial Hypertension - July 14, 2005
Encysive Pharmaceuticals Submits New Drug Application for Thelin - May 25, 2005
New Drug Applications Archive
2008: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
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
