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Junior Member
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Join Date: Jan 2014
Location: Apex, NC
Posts: 17
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Junior Member
Join Date: Jan 2014
Location: Apex, NC
Posts: 17
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on February 25, 2008 (local time) a Not approvable letter from the U.S. Food and Drug Administration (FDA) for istradefylline (KW-6002), its investigational drug for the treatment of Parkinson's disease.
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In the not approvable letter FDA expressed concern if the efficacy findings support clinical utility of istradefylline (KW-6002). FDA requested an overall summary of nonclinical mineralization findings. Additionally, FDA asked for clinical pharmacology follow-up information as a Phase 4 commitment.
After closely examining the FDA's response, Kyowa Hakko will work closely with FDA and conduct a comprehensive discussion to determine a path forward for istradefylline (KW-6002).
Last edited by Chemar; 01-30-2014 at 01:15 PM.
Reason: sorry no links allowed under a certain post count as per guidelines
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