Thelin
Generic name: sitaxsentan
Treatment for: Pulmonary Arterial Hypertension (PAH)
Encysive Pharmaceuticals Receives Approvable Letter From FDA for Thelin
HOUSTON, March 24, 2006 -- Encysive Pharmaceuticals today announced that the Company has 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). The action letter contains concerns and observations that must be satisfied prior to achieving approval, including a request for additional clinical trial work.
"We will work in close collaboration with the FDA to clarify the path forward. We are hopeful that this can be accomplished without the need for additional clinical work, but that will require discussion with the Agency before we can be sure," said Bruce D. Given, M.D., President and Chief Executive Officer of Encysive Pharmaceuticals. "We remain confident in Thelin's value, and look forward to the opportunity to provide PAH patients with a new treatment option."
Posted: March 2006
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Thelin (sitaxsentan) FDA Approval History
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