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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

DateArticle
Sep  6, 2007Encysive Pharmaceuticals Receives Written Response From FDA On Its Request for Formal Dispute Resolution for Thelin (Sitaxsentan Sodium)
Aug  7, 2007Encysive Pharmaceuticals Files Request for Formal Dispute Resolution With U.S. FDA to Contest Third Approvable Letter for Thelin
Jul 13, 2007Encysive Pharmaceuticals Provides Update for Thelin (Sitaxsentan Sodium)
Jun 18, 2007FDA Issues Third Approvable Letter for Thelin (Sitaxsentan Sodium)
Dec 28, 2006FDA Accepts Encysive’s Complete Response to Thelin New Drug Application
Dec 15, 2006Encysive Pharmaceuticals Submits Response to FDA For Thelin New Drug Application
Dec 14, 2006Encysive Expects to Submit Revised Response to Thelin Approvable Letter Within Several Days
Nov  2, 2006Encysive Submits Complete Response to FDA For Thelin New Drug Application
Jul 24, 2006FDA Issues Approvable Letter for Thelin; One Outstanding Item Remains
Jun 15, 2006FDA Grants Class 1 Review to Encysive Pharmaceuticals’ Complete Response to Thelin NDA
May 25, 2006Encysive Pharmaceuticals Submits Complete Response to FDA for Thelin New Drug Application
Mar 24, 2006Encysive Pharmaceuticals Receives Approvable Letter From FDA for Thelin
Jul 14, 2005Encysive Announces PDUFA Date for Thelin New Drug Application in Pulmonary Arterial Hypertension
May 25, 2005Encysive Pharmaceuticals Submits New Drug Application for Thelin

Further information

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