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Appendix A: Study Cohort

 Planned Review Timelines Assessment: Table of Contents

 

NDA/ BLA #

Application Received Date

Action Taken

Center

Office

Division/ Office

Standard/ Priority

PMRs/ PMCs

AC Meeting

Included Timelines in Filing Communication

Met Target Date

22288

11/12/08

Approval

CDER

OAP

DAIOP

S

N

Y

Y

Did Not Meet

22408

1/22/09

CR***

CDER

ODEIII

DDDP

S

N

**

Y

Pending

22393

1/12/09

Approval

CDER

OODP

DDOP

S

Y

Y

Y

Pending

22465

12/19/08

Approval

CDER

OODP

DDOP

S

Y

Y

N*

N/A

22562

6/18/09

Approval

CDER

ODEIII

DGP

P

Y

Y

N*

N/A

22363

10/3/08

Approval

CDER

ODEII

DMEP

S

Y

N

N

N/A

22505

5/29/09

Pending***

CDER

ODEII

DMEP

S

N

**

Y

Pending

22454

3/9/09

CR***

CDER

ODEIV

DMIP

P

N

Y

Y

Did Not Meet

22399

1/9/09

CR***

CDER

ODEI

DNP

S

N

**

Y

Pending

22522

7/17/09

CR***

CDER

ODEII

DPARP

S

N

**

Y

Pending

125293

10/31/08

CR***

CDER

ODEII

DPARP

P

Y

Y

Y

Did Not Meet

125319

12/17/08

Approval

CDER

ODEII

DPARP

P

Y

**

N

N/A

125338

2/27/09

Approval

CDER

ODEII

DPARP

P

Y

Y

Y

Did Not Meet

22252

7/6/09

Approval

CDER

ODEIII

DRUP

S

Y

N

Y

Pending

125320

12/19/08

CR***

CDER

ODEIII

DRUP

S

N

**

Y

Pending

125350

4/30/09

Approval

CBER

OBRR

OBRR

S

Y

N

Y

Did Not Meet

125347

3/17/09

Approval

CBER

OVRR

OVRR

P

Y

N

Y

Met Timeline

125324

3/31/09

Approval

CBER

OVRR

OVRR

P

Y

**

Y

Unsolicited Amendments

125351

6/5/09

Approval

CBER

OBRR

OBRR

S

Y

N

Y

Met Timeline

*Information was redacted from the applications below to protect confidentiality.

 

 

CR

 

 

 

P

N

**

Y

Pending

 

 

CR

 

 

 

S

N

N

Y

Did Not Meet

 

 

CR

 

 

 

S

N

**

N*

N/A

 

 

Withdrawn

 

 

 

S

N

**

Y

Pending

 

 

CR

 

 

 

S

N

**

Y

Pending

 

 

CR

 

 

 

S

N

N

Y

Met Timeline

 

 

CR

 

 

 

S

N

**

N

N/A

 

 

CR

 

 

 

S

N

Y

Y

Did Not Meet

 

 

CR

 

 

 

S

N

**

Y

Pending

 

 

CR

 

 

 

S

N

**

Y

Pending

 

 

CR

 

 

 

S

N

**

Y

Pending

 

 

CR

 

 

 

P

N

N

Y

Met Timeline

 

 

CR

 

 

 

P

N

**

Y

Unsolicited Amendments

 

 

CR

 

 

 

S

N

Y

Y

Did Not Meet

 

 

CR

 

 

 

P

N

**

Y

Pending

 

 

CR

 

 

 

S

N

N

Y

Did Not Meet

 

 

CR

 

 

 

S

N

**

Y

Pending

 

Notes: * NDA22-465 , and NDA 22-562 were deemed to have not included the timelines in the filing communication in the FY09 report, but were counted among those that did include the timelines in the revised data released with the FY10 performance report.

**The presence of an Advisory Committee meeting was only determined for applications that included planned review timelines in the Filing Communication letter and had reached the communicated dates by the end of FY09.
*** Application has since been approved.
 
Next Secton: Appendix B: Updated FY09 Planned Review Timelines Data