Drugs
Drug and Biologic Approval Reports
On June 30, 2003, FDA transferred some of the therapeutic biological products that had been reviewed and regulated by the Center for Biologics Evaluation and Research (CBER) to the Center for Drug Evaluation and Research (CDER). CDER now has regulatory responsibility, including premarket review and continuing oversight, over the transferred products. In regulating the products assigned to them, CBER and CDER will consult with each other regularly and whenever necessary. The links below contain tables that consist of drug and biologic approvals by CDER only. For CBER biologic approvals, please visit: CBER Approvals by Year
NDA Approvals by Therapeutic Potential and Chemical Type
IND Reports
NDA and BLA Approvals
NME Drug and New Biologic Approvals
CDER New Molecular Entity (NME) Drug and New Biologic Approvals
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CDER New Molecular Entity (NME) and New Biologic Approvals Calendar Year 2012 (PDF - 52KB) -
CDER New Molecular Entity (NME) and New Biologic Approvals Calendar Year 2011 (PDF - 266KB) - CDER New Molecular Entity (NME) and New Biologic Approvals Calendar Year 2010 (PDF - 129KB)
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NME Drug and New Biologic Approvals in 2009 (PDF - 138KB)
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 in Calendar Year 2012 (PDF - 26KB)CDER Priority Drug and Biologic Approvals in Calendar Year 2011 (PDF - 76KB)CDER Priority Drug and Biologic Approvals in Calendar Year 2010 (PDF - 77KB)- CDER Priority Drug and Biologic Approvals in Calendar Year 2009 (PDF - 64KB)
Efficacy Supplement Approvals
New Drug Application (NDA) and Biologic License Application (BLA) Efficacy Supplement Calendar Year Approvals
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New Drug Application (NDA) and Biologic License Application (BLA) Efficacy Supplement Calendar Year Approvals: 2012 (PDF - 56KB) -
New Drug Application (NDA) and Biologic License Application (BLA) Efficacy Supplement Calendar Year Approvals: 2011 (PDF - 83KB) - New Drug Application (NDA) and Biologic License Application (BLA) Efficacy Supplement Calendar Year Approvals: 2010 (PDF - 186KB)
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New Drug Application (NDA) Efficacy Supplements Calendar Year Approvals: 2009
Accelerated Approvals
Accelerated and Restricted Approvals Under Subpart H (drugs) and Subpart E (biologics)
