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 CDER Drug and Biologic Approval Reports
(CDER biologic approvals beginning in 2004)


Approval Times

New Drug Applications (NDAs) & Biologic License Applications (BLAs)

New Molecular Entity Drugs (NMEs) & New Biologics (New BLAs)


NDA and BLA Approvals

         2008          2007         2006        2005        2004        2003        2002        2001        2000        1999


NME Drug and New Biologic Approvals

          2008        2007        2006        2005        2004        2003        2002        2001        2000        1999


Priority NDA and BLA Approvals

          2008        2007        2006        2005        2004        2003        2002        2001        2000        1999


Efficacy Supplement Approvals

          2008        2007        2006        2005        2004        2003        2002       2001        2000        1999        1998


Accelerated and Restricted Approvals Under Subpart H (drugs) and Subpart E (biologics)

         NDAs, NDA Supplements, BLAs, and BLA Supplements      


Fast Track Reports

Approvals

Statistics (Current Fiscal Year)

Statistics (Fiscal Year 1998-2006)


NDA Approvals by Therapeutic Potential and Chemical Type


Number of NDA Receipts by Calendar Year


First Action Performance Reports ─ Cohort Closeout Statistics (Fiscal Years)

              Original NDAs                                                                NDA Resubmissions

          Original Efficacy Supplements                                  Efficacy Supplement Resubmissions

          Original Manufacturing Supplements


Approval Rates by Cohort Year of Receipt (Fiscal Years)

              CDER Priority NDAs & BLAs PDF

          CDER Standard NDAs & BLAs PDF


IND Reports

          Active INDs

          IND Receipts


To access approval letters, labels, and review packages, go to Drugs at FDA Logo links back to Initial Search Page


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Date updated: August 15, 2008

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