CDER New Molecular Entity (NME)
Drug in Calendar Year 2007
Updated through February 29, 2008
NME New Drug Application (NDA) Approvals:
|
NDA Number |
Proprietary Name |
Established Name |
Applicant |
Review Classification |
Approval Date |
|
N022187 |
Intelence |
etravirine |
Tibotec |
P |
18-Jan-08 |
|
N021992 |
Pristiq |
desvenlafaxine succinate |
Wyeth |
S |
29-Feb-08 |
New Biologic License Application (BLA) Approvals:
|
BLA Number |
Proprietary
Name |
Established
Name |
Applicant |
Review Classification |
Approval Date |
|
125249 |
Arcalyst |
rilonacept |
Regeneron |
P,O |
27- Feb-2008 |
|
125164 |
Mircera |
methoxy polyethylene glycol -epoetin
beta |
Hoffman La-Roche |
S |
14- Nov-07 |
Click here
to view table showing NMEs Approved in Calendar Year 2007 (Updated upto
November 30, 2007)
Click here
to view table showing NMEs Approved in Calendar Year 2006 (Updated upto
November 30, 2006)
Click here to view table
showing NMEs Approved in Calendar Year 2005 (Updated upto November 30, 2005)
Click here to view table
showing NMEs Approved in Calendar Year 2004 (Updated upto July 31, 2005)
Click here to view table
showing NMEs Approved in Calendar Year 2004 (Updated upto December 31, 2004)
Click here to view table
showing NMEs Approved in Calendar Year 2004 (Updated upto November 30, 2004)
Click here to view table
showing NMEs Approved in Calendar Year 2004 (Updated upto September 30, 2004)
Click here to view table showing NMEs Approved in Calendar Year 2003
Click here to view table showing NMEs Approved in Calendar Year 2002
Review Classification:
P - Priority Review - Significant
improvement compared to marketed products, in the treatment,
diagnosis, or prevention of a disease.
S - Standard Review - Products that do not qualify for priority review.
V - Orphan Drug
-
Pursuant to Section 526 of the Orphan Drug Act (Public Law 97-414 as amended). |