Xinlay FDA Approval Status
FDA Approved: No
Brand name: Xinlay
Generic name: atrasentan
Treatment for: Prostate Cancer
Xinlay (atrasentan) is a selective endothelin-A receptor antagonist intended for the treatment of hormone-refractory prostate cancer (HRPC).In October 2005, Abbott received a not-approvable letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for the oral investigational agent Xinlay. The FDA’s Oncologic Drugs Advisory Committee (ODAC) recommended against the approval of Xinlay in September 2005.
Development Timeline for Xinlay
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