NDA and BLA Approvals

• CDER Drug and Biologic Approvals for Calendar Year 2009 (PDF - 58KB) 

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 - 34KB) 
• NME Drug and New Biologic Approvals in 2008 (PDF - 33KB) 

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

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

• CDER Drug and Biologic Approvals for Calendar Year 2009 (PDF - 58KB) 
• Priority NDA and BLA Approvals in 2008 (PDF - 45KB) 

Efficacy Supplement Approvals

Efficacy Supplement Approvals

• New Drug Application (NDA) & Biologic License Application (BLA) Efficacy Supplements Approved (CY2009) (PDF - 79KB) 
• Efficacy Supplement Approvals in 2008 (PDF - 178KB) 

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

• Fast Track Approvals 
• Fast Track Statistics (Current Fiscal Year) 
• Fast Track (Prior Years)