CDER New Molecular Entity (NME) Drug in Calendar Year 2007
Updated through November 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
N022249 TREANDA BENDAMUSTINE HYDROCHLORIDE CEPHALON P 20-Mar-08
N022161 LEXISCAN REGADENOSON CV THERAPEUTICS S 10-Apr-08
N021964 RELISTOR METHYLNALTREXONE BROMIDE PROGENICS S 24-Apr-08
N021775 ENTEREG ALVIMOPAN ADOLOR S 20-May-08
N022212 DUREZOL DIFLUPREDNATE SIRION P 23-Jun-08
N022090 EOVIST INJECTION GADOXETATE DISODIUM BAYER S 3-Jul-08
N022156 CLEVIPREX CLEVIDIPINE BUTYRATE MEDICINES COMPANY S 1-Aug-08
N021894 XENAZINE TETRABENAZINE PRESTWICK P 15-Aug-08
N022290 ADRE VIEW IOBENUANE I 123 INJECTION GE HEALTHCARE P 19-Sep-08

 

New Biologic License Application (BLA) Approvals:

BLA Number Proprietary
Name		 Established
Name		 Applicant Review Classification Approval Date
125268 NPLATE ROMIPLOSTIM AMGEN P 22- Aug-2008
125160 CIMZIA CERTOLIZUMAB PEGOL UCB S 22- Apr-2008
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).