NDA and BLA Approvals

• CDER Drug and Biologic Approvals for Calendar Year 2009 (PDF - 109KB) 
• CDER Drug and Biologic Approvals for Calendar Year 2008 (PDF - 92KB) 

NME Drug and New Biologic Approvals

CDER New Molecular Entity (NME) Drug and New Biologic Approvals

• NME Drug and New Biologic Approvals in 2009 (PDF - 80KB) 
• NME Drug and New Biologic Approvals in 2008 (PDF - 46KB) 

Priority New Drug Application (NDA) and Biologic License Application (BLA) Approvals

Priority New Drug Application (NDA) and Biologic License Application (BLA) Approvals

• CDER Priority Drug and Biologic Approvals: Calendar Year 2009 
• Priority NDA and BLA Approvals in 2008 (PDF - 45KB) 

Efficacy Supplement Approvals

Efficacy Supplement Approvals

• New Drug Application (NDA) Efficacy Supplements Calendar Year Approvals: 2009 
• New Drug Application (NDA) & Biologic License Application (BLA) Efficacy Supplements (CY2008) (PDF - 192KB) 

Approval Reports

• New Drug Applications (NDAs) & Biologic License Applications (BLAs) (PDF - 21KB) 
• New Molecular Entity Drugs (NMEs) & New Biologics (New BLAs) (PDF - 47KB) 

Fast Track Reports

• NDA Fast Track Approvals (PDF - 233KB) 
  Updated 6/1/2010