ThelinTreatment for Pulmonary Arterial Hypertension (PAH)
FDA Accepts Encysive’s Complete Response to Thelin New Drug Application
Conference Call Scheduled for Today at 2:15 p.m. Eastern Time
HOUSTON, December 28, 2006 -- Encysive Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Company's complete response to the July 24, 2006 approvable letter regarding its New Drug Application (NDA) for Thelin (sitaxsentan sodium) 100 mg tablets. The FDA has designated the review as a Class 2 resubmission and issued a new Prescription Drug User Fee Act (PDUFA) target action date of June 15, 2007.
Thelin is currently being evaluated by the FDA as a potential new oral treatment for patients with pulmonary arterial hypertension (PAH).
The Company will work with the FDA to schedule a meeting as soon as possible in an effort to clarify the situation and move the application forward.
Encysive is currently in the process of commercializing Thelin 100 mg in the European Union, following the August 2006 receipt of marketing authorization from the European Commission. To date, Thelin has been launched in the United Kingdom and Germany.
Posted: December 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
- 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
- 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