ThelinTreatment for Pulmonary Arterial Hypertension (PAH)
FDA Grants Class 1 Review to Encysive Pharmaceuticals’ Complete Response to Thelin NDA
Agency Assigns 60-Day PDUFA Target Action Date
HOUSTON, June 15, 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 March 24 approvable letter regarding its New Drug Application (NDA) for Thelin (sitaxsentan sodium) 100 mg tablets. The FDA has designated the review as a Class 1 resubmission and issued a new Prescription Drug User Fee Act (PDUFA) target action date of July 24, 2006 for the Thelin NDA.
Thelin is currently being evaluated by the FDA as a potential new oral treatment for patients with pulmonary arterial hypertension.
Encysive recently received a positive opinion recommending the approval of Thelin 100 mg tablets by the Committee for Medicinal Products for Human Use (CHMP) of the European Agency for the Evaluation of Medicinal Products (EMEA). A final decision for European approval is expected within 90 days of the CHMP positive opinion.
Posted: June 2006
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- Encysive Pharmaceuticals Submits Response to FDA For Thelin New Drug Application - December 15, 2006
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- Encysive Submits Complete Response to FDA For Thelin New Drug Application - November 2, 2006
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- 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