Xinlay Approval Status
- FDA approved: No
- Brand name: Xinlay
- Generic name: atrasentan
- Company: Abbott
- 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 Status and FDA Approval Process for Xinlay
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