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NME Class of 2006?

NME Class of 2006?



These 23 drugs have been assigned user fee dates in 2006 and could be among the new molecular entities approved this year, based on public disclosure.

Drug

Company

Estimated Action Date

Acomplia

Sanofi-Aventis

2/2006

Arformoterol

Sepracor

10/13/2006*

Champix

Pfizer

5/2006

Dacogen

MGI/SuperGen

5/15/2006

Dasatinib

Bristol-Myers Squibb

6/28/2006 or 10/28/2006* (Priority review requested)

Desvenlafaxine

Wyeth

10/22/2006

Dronedarone

Sanofi-Aventis

4/2006

Exubera

Pfizer/Sanofi-Aventis

1/27/2006

Genasense

Genta

6/29/2006 or 10/29/2006** (Priority review requested)

Hexvix

PhotoCure ASA

4/30/2006

Indiplon

Pfizer/Neurocrine

2/15/2006

Lubiprostone

Sucampo

1/31/2006

Neupro

Schwarz

2/28/2006

NRP104

Shire/New River

6/6/2006 or 10/6/2006**

Nuvigil

Cephalon

1/31/2006

Paliperidone

Johnson & Johnson

9/29/2006

Polyphenon E

MediGene AG

7/28/2006*

Ranexa

CV Therapeutics

1/27/2006

Rufinamide

Eisai

9/16/2006

Sutent

Pfizer

2/10/2006

Telbivudine

Novartis/Idenix

11/3/2006*

Thelin

Encysive

3/24/2006

TMC-114

Johnson & Johnson

6/23/2006 or 10/23/2006**

* Date based on announcement of submission; approval could come earlier
** Status as priority or standard review unknown

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