Thelin
Generic name: sitaxsentan
Treatment for: Pulmonary Arterial Hypertension (PAH)
FDA Issues Approvable Letter for Thelin; One Outstanding Item Remains
Conference Call Scheduled for Tuesday, July 25 at 8:00 a.m. ET
HOUSTON, July 24, 2006 -- Encysive Pharmaceuticals today announced that at 4:35 p.m. ET the Company received an approvable letter from the U.S. Food and Drug Administration (FDA) for Thelin (sitaxsentan sodium), which is under review for the treatment of pulmonary arterial hypertension (PAH). Of the substantive items raised in the March 24, 2006 approvable letter, one remains unresolved.
In today's approvable letter, the FDA acknowledged that the unresolved item is a matter of judgment and expressed an openness to consider new arguments to address this remaining item. The FDA again offered the alternative of conducting additional clinical work. Additionally, the FDA provided recommendations on the Company's risk management plan, which the Company views as constructive.
Posted: July 2006
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Thelin (sitaxsentan) FDA Approval History
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