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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

DateArticle
Sep 13, 2005FDA Advisory Committee Does Not Recommend Approval of Xinlay (atrasentan)
Feb 11, 2005FDA Agrees to File Abbott's New Drug Application for Xinlay (Atrasentan) to Treat Metastatic Hormone-Refractory Prostate Cancer
Dec 14, 2004Abbott Submits New Drug Application to U.S. FDA for Advanced Prostate Cancer Drug, Xinlay (atrasentan)

Further information

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