Skip to Content

Thelin

Treatment 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

Related Articles

Thelin (sitaxsentan) FDA Approval History

More News Resources

Subscribe to our Newsletter

Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.