FDA accepts Exelixis’ cabozantinib NDA for filing

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Jul 30 2012Exelixis, Inc.

Exelixis, Inc. (NASDAQ:EXEL) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for cabozantinib as a treatment for patients with progressive, unresectable, locally advanced, or metastatic medullary thyroid cancer (MTC). The FDA also granted priority review designation to the NDA for cabozantinib.

The Prescription Drug User Fee Act (PDUFA) action date is November 29, 2012. Priority Review is granted to a pharmaceutical product that, if approved, would meet an unmet medical need for a serious and life-threatening condition.    

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Exelixis, Inc.

Posted in: Medical Condition News | Pharmaceutical News

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