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

Approval Times (In Months) for Priority and Standard NMEs and NDAs (In Months)

1. Approval Times for Priority and Standard NMEs - Calendar Years 1993-2003 (Updated through 12/31/2003, Posted 1/21/2004)
2. Approval Times for Priority and Standard NDAs - Calendar Years 1993-2003 (Updated through 12/31/2003, Posted 1/30/2004)

NDA Accelerated Approvals Report

1. NDAs Approved under Subpart H (Updated through 9/30/2004, Posted 10/25/2004)  

2. NDA Supplements Approved under Subpart H (Updated through 9/30/2004, Posted 10/25/2004)  

3. Biological Products Approved under Subpart E (Updated through 9/30/2004, Posted 10/25/2004)

Fast Track Designation Reports

1. Fast Track Designated Products Approved since 1998 (Updated through 9/30/2004, Posted 10/28/2004) 
2. CDER Response to Request for Fast Track Designation  (Updated through 9/30/2004, Posted 10/28/2004) 

New Molecular Entity (NME) Drug and New Biologic Reports

1. New Molecular Entity (NME) Drug and New Biologic Approvals in Calendar Year 2004  (Updated through 9/30/2004, Posted 10/25/2004)
2. New Molecular Entities (NMEs) Approved in Calendar Year 2003  (Updated through 12/31/2003, Posted 1/21/2004)
3. New Molecular Entities (NMEs) Approved in Calendar Year 2002  (Updated through 12/31/2002, Posted 1/8/2003)
4. New Molecular Entities (NMEs) Approved in Calendar Year 2001 (Updated through 12/31/2001, Posted 10/24/2002) 
   List of NMEs approved in calendar year 2001.
5. New Molecular Entities (NMEs) Approved in Calendar Year 2000 (Updated 4/6/2001) 
   List of NMEs approved in calendar year 2000
6. New Molecular Entities (NMEs) Approved in Calendar Year 1999 (Updated 4/6/2001) 
   List of NMEs approved in calendar year 1999.
7. New Molecular Entities (NMEs) Approved in Calendar Year 1998 (Updated 4/6/2001) 
   List of NMEs approved in calendar year 1998

Investigational New Drugs (INDs) Reports

1. Active Investigational New Drugs (INDs) at the Close of the Calendar Year - Calendar Years 1986-2003 (Updated through 12/31/2003, Posted 1/21/2004) 
   List of active Commercial and Non-Commercial Investigational New Drugs at the close of each Calendar Year beginning with 1986 through 2003 
2. INDs Received Calendar Years 1986-2003 (Updated through 12/31/2003, Posted 1/21/2004) 
   Total number of Commercial and Non-Commercial Investigational New Drugs received in each calendar year beginning with 1986 through 2003

First Action Performance Reports (FY Cohort Closeout Stats)

1. First Action Performance For Original Manufacturing Supplements (Updated through 10/31/2002, Posted 5/27/2004)
2. First Action Performance For Original Efficacy Supplements (Updated through 10/31/2002, Posted 5/27/2004)
3. First Action Performance For Original NDAs (Updated through 10/31/2002, Posted 5/27/2004)
4. First Action Performance For Resubmitted NDAs (Updated through 10/31/2002, Posted 5/27/2004)

New Drug Applications Approved by Therapeutic Potential and Chemical Types

1. NDAs Approved in Calendar Years 1990-2003 by Therapeutic Potential and Chemical Types (Updated through 12/31/2003, Posted 1/21/2004)

New Drug Application (NDA) and Biologic License Application (BLA) Approvals by Calendar Year

1. NDA and BLA Approvals for Calendar Year 2004 (Updated through 9/30/2004, Posted 10/25/2004) 
2. NDA Approvals for Calendar Year 2003 (Updated through 12/31/2003, Posted 1/21/2004) 
3. NDA Approvals for Calendar Year 2002 (Updated through 12/31/2002, Posted 1/14/2003) 
4. NDA Approvals for Calendar Year 2001 (Updated through 12/31/2001,  Posted 7/15/2002) 
5. NDA Approvals for Calendar Year 2000 (Updated 4/19/2002) 
6. NDA Approvals for Calendar Year 1999 (Updated 4/19/2002) 
7. NDA Approvals for Calendar Year 1998 (Updated 4/6/2001) 

Efficacy Supplements Approved in Calendar Year

1. Efficacy Supplements Approved in Calendar Year 2004 (Updated through 6/30/2004, Updated 7/29/2004) 
2. Efficacy Supplements Approved in Calendar Year 2003 (Updated through 12/31/2003, Updated 3/19/2004) 
3. Efficacy Supplements Approved in Calendar Year 2002 (Updated through 12/31/2002, Posted 1/14/2003) 
4. Efficacy Supplements Approved in Calendar Year 2001 (Updated through 12/31/2001, Posted 10/24/2002) 
5. Efficacy Supplements Approved in Calendar Year 2000 (Updated 3/19/2002)
6. Efficacy Supplements Approved in Calendar Year 1999 (Updated 3/19/2002)
7. Efficacy Supplements Approved in Calendar Year 1998 (Posted 3/19/2002) 

Efficacy Supplements Approved in Fiscal Year

1. Efficacy Supplements Approved in  Fiscal Year 2004 (Updated through 9/30/2004) 

2. Efficacy Supplements Approved (Biologics) in Fiscal Year 2004 (Updated through 9/30/2004)

 Number of NDAs Received by Calendar Year

1. Number of NDAs Received by Calendar Year (Updated through 12/31/2003, Posted 1/21/2004)
   

Fiscal Year User Fee NME Drug and New Biologic Approvals

• FY 2004 User Fee NME Drug and New Biologic Approvals (Updated through 9/30/2004, Posted 10/25/2004)
• FY 2003 User Fee NME Approvals (Updated through 9/30/2003, Posted 10/29/2003)
• FY 2002 User Fee NME Approvals (Updated through 9/30/2002, Posted 10/24/2002)
• FY 2001 User Fee NME Approvals (Updated through 9/30/2001)
• FY 2000 User Fee NME Approvals (Updated 4/6/2001)

Fiscal Year User Fee Priority Approvals

• FY 2004 Priority Approvals (Updated through 9/30/2004, Posted 10/25/2004)
• FY 2003 Priority Approvals (Updated through 9/30/2003, Posted 10/29/2003)

• FY 2002 User Fee Priority Approvals (Updated 10/24/2002)

• FY 2001 User Fee Priority Approvals (Updated through 9/30/2001)

• FY 2000 User Fee Priority Approvals (Updated 4/6/2001) 

New Drug Approval Rates 

• NDA Approval Rates for Standard NDAs Received FY 93-03 and Approved within 36 Months (Updated through 3/31/2004, Posted 5/17/2004)

• NDA Approval Rates for Priority NDAs Received FY 93-03 and Approved within 36 Months (Updated through 3/31/2004, Posted 5/17/2004)

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Date updated: October 25. 2004

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