Summary of New Drug Applications and Biologic License Applications Submitted to the Food and Drug Administration

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Abstract

From February 2004 through April 2004 the pharmaceutical industry submitted 12 New Drug Applications (NDA) or Biologic Licence Applications (BLA) to the Food and Drug Administration for review and approval. A brief summary is provided for most of these new drugs or dosage forms. In addition, Table 1 is a summary of the NDAs and BLAs that were filed with the Food and Drug Administration during that time frame and Table 2 is a summary of earlier NDAs and BLAs submitted to the Food and Drug Administration since October 2001 that have not yet been approved or denied approval.

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