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Advexin FDA Approval Status

FDA Approved: No
Brand name: Advexin
Generic name: p53 tumor suppressor therapy
Company: Introgen Therapeutics, Inc.
Treatment for: Head and Neck Cancer

Advexin is an investigational targeted molecular therapy for the treatment of head and neck cancer.

In September 2008, Introgen Therapeutics, Inc. announced the receipt Refuse to File Letter from the U.S. Food and Drug Administration (FDA), advising the company that the Biologics License Application (BLA) for Advexin was not sufficiently complete and would not be filed at that time.

Development timeline for Advexin

Sep  2, 2008Introgen Receives Notice Advexin U.S. BLA Not Sufficiently Complete to File
Jun 30, 2008Introgen Submits Advexin Regulatory Applications in the U.S. and Europe
Dec 20, 2007Introgen Plans to Expand Biomarker Database in Phase 3 Trials and File BLA and MAA for Advexin in Advanced Head and Neck Cancer in First Half of 2008

Further information

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