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May 10th, 2004
APP Announces FDA Acceptance of New Drug
American Pharmaceutical Partners, Inc. and American BioScience, Inc.today announced that the New Drug Application for ABRAXANETM has been accepted for filing with standard review by the U.S. Food and Drug Administration, indicating the FDA has determined that the application is sufficiently complete to permit a substantive review. The final portion of the NDA was submitted on March 8, 2004 under FDA's Fast Track designation, as a treatment for metastatic breast cancer.
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