Skip to Content

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, 2008Kyowa Hakko Receives Not Approvable Letter from FDA for Istradefylline (KW-6002)
Apr 27, 2007Submission of NDA for Istradefylline (KW-6002), anInvestigational Anti-Parkinson's Disease Drug

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.