KW-6002 Approval Status
- FDA approved: No
- Brand name: KW-6002
- Generic name: istradefylline
- Company: Kyowa Pharmaceutical, Inc.
- Treatment for: Parkinson's Disease
Istradefylline (KW-6002) is an investigational adenosine A2A receptor antagonist intended for the treatment of Parkinson's disease.
In February 2008, Kyowa Pharmaceutical, Inc. announced the receipt of a Not Approvable Letter from the U.S. Food and Drug Administration (FDA) advising the company that the New Drug Application (NDA) for KW-6002 had not been approved.
Development Status and FDA Approval Process for KW-6002
|Feb 28, 2008||Kyowa Hakko Receives Not Approvable Letter from FDA for Istradefylline (KW-6002)|
|Apr 27, 2007||Submission of NDA for Istradefylline (KW-6002), anInvestigational Anti-Parkinson's Disease Drug|
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