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Nourianz FDA Approval History

Last updated by Judith Stewart, BPharm on Nov 29, 2019.

FDA Approved: Yes (First approved August 27, 2019)
Brand name: Nourianz
Generic name: istradefylline
Dosage form: Tablets
Company: Kyowa Kirin, Inc.
Treatment for: Parkinson's Disease

Nourianz (istradefylline) is an adenosine A2A receptor antagonist indicated for use as an adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson’s disease (PD) experiencing “OFF” episodes.

Development timeline for Nourianz

Aug 28, 2019Approval FDA Approves Nourianz (istradefylline) as an Add-On Drug to Treat Off Episodes in Adults with Parkinson’s Disease
Apr  4, 2019Kyowa Kirin Announces FDA Acceptance of Istradefylline (KW-6002) New Drug Application Resubmission in the US
Feb 28, 2008Kyowa Hakko Receives Not Approvable Letter from FDA forIstradefylline (KW-6002)
Apr 27, 2007Submission of NDA for Istradefylline (KW-6002), an Investigational Anti-Parkinson's Disease Drug

Further information

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