Thelin FDA Approval Status
FDA Approved: No
Brand name: Thelin
Generic name: sitaxsentan
Company: Encysive Pharmaceuticals
Treatment for: Pulmonary Arterial Hypertension
Thelin is an endothelin receptor antagonist currently being evaluated by the FDA as a potential new oral treatment for patients with pulmonary arterial hypertension (PAH).
Development timeline for Thelin
| Date | Article |
|---|
| Sep 6, 2007 | Encysive Pharmaceuticals Receives Written Response From FDA On Its
Request for Formal Dispute Resolution for Thelin (Sitaxsentan
Sodium) |
| Aug 7, 2007 | Encysive Pharmaceuticals Files Request for Formal Dispute
Resolution With U.S. FDA to Contest Third Approvable Letter for Thelin |
| Jul 13, 2007 | Encysive Pharmaceuticals Provides Update for Thelin (Sitaxsentan
Sodium) |
| Jun 18, 2007 | FDA Issues Third Approvable Letter for Thelin (Sitaxsentan Sodium) |
| Dec 28, 2006 | FDA Accepts Encysive’s Complete Response to Thelin New Drug Application |
| Dec 15, 2006 | Encysive Pharmaceuticals Submits Response to FDA For Thelin New Drug Application |
| Dec 14, 2006 | Encysive Expects to Submit Revised Response to Thelin Approvable Letter Within Several Days |
| Nov 2, 2006 | Encysive Submits Complete Response to FDA For Thelin New Drug Application |
| Jul 24, 2006 | FDA Issues Approvable Letter for Thelin; One Outstanding Item Remains |
| Jun 15, 2006 | FDA Grants Class 1 Review to Encysive Pharmaceuticals’ Complete Response to Thelin NDA |
| May 25, 2006 | Encysive Pharmaceuticals Submits Complete Response to FDA for Thelin New Drug Application |
| Mar 24, 2006 | Encysive Pharmaceuticals Receives Approvable Letter From FDA for Thelin |
| Jul 14, 2005 | Encysive Announces PDUFA Date for Thelin New Drug Application in Pulmonary Arterial Hypertension |
| May 25, 2005 | Encysive Pharmaceuticals Submits New Drug Application for Thelin |
Further information
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