ThelinTreatment for Pulmonary Arterial Hypertension (PAH)
Encysive Submits Complete Response to FDA For Thelin New Drug Application
HOUSTON, November 2, 2006 -- Encysive Pharmaceuticals announced that following discussions today with the U.S. Food and Drug Administration (FDA), the Company has submitted a complete response to the July 24, 2006 approvable letter issued by the FDA regarding the Company's New Drug Application (NDA) for Thelin (sitaxsentan sodium) 100 mg tablets. The FDA is currently evaluating Thelin as a potential new oral treatment for pulmonary arterial hypertension.
The Company expects to hear within approximately 30 days whether the FDA accepts the submission and if so, the FDA will establish a new PDUFA action date.
Posted: November 2006
- 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 Pharmaceuticals Submits Response to FDA For Thelin New Drug Application - December 15, 2006
- Encysive Expects to Submit Revised Response to Thelin Approvable Letter Within Several Days - December 14, 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
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