Encysive submits complete response to FDA on New Drug Application for Thelin

By E. Janene Geiss

Philadelphia, May 25 - Encysive Pharmaceuticals said Thursday it submitted a complete response to concerns and observations noted in a March 24 approvable letter issued by the Food and Drug Administration regarding the company's New Drug Application for Thelin (sitaxsentan sodium) 100 mg.

The FDA is evaluating Thelin as a potential new oral treatment for pulmonary arterial hypertension, according to a company news release.

"Encysive and the FDA have come to the mutual agreement that the company's approach to responding to the items outlined in the approvable letter with our existing data set is reasonable, making possible the submission of a complete response," Bruce D. Given, president and chief executive officer of Encysive, said in the release.

The company said it expects to hear within 30 days whether the FDA accepts the submission for review.

Encysive is a Houston biopharmaceutical company.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.