CDER Drug and Biologic Approvals for Calendar Year 2008
Updated through January 31, 2008

 

New Drug Application (NDA) Approvals:

NDA Number	Proprietary Name	Established Name	Applicant	Chemical Type	Review Classification	Approval Date
N021658	Alvesco	ciclesonide	Nycomed	3	S	10-Jan-2008
N022067	Flo-Pred	prednisolone acetate	Taro	3	S	17-Jan-2008
N022107	Tekturna HCT	aliskiren/hydrochlorothiazide	Novartis	4	S	18-Jan-2008
N022187	Intelence	etravirine	Tibotec	1	P	18-Jan-2008
N021538	Accretropin	somatropin	Chesapeake	5	S	23-Jan-2008
N050813	Moxatag	amoxicillin	MiddleBrook	3	S	23-Jan-2008
N022023	Emend	fosaprepitant dimeglumine	Merck & Co	2	S	25-Jan-2008
N022157	Xyzal	levocetirizine dihydrochloride	UCB, Inc.	3	S	28-Jan-2008
N022078	Simcor	niacin/simvastatin	Abbott	4	S	15-Feb-2008
N022029	Salonpas	methyl salicylate & menthol	Hisamitsu	3,4	S	20-Feb-2008
N022028	Cosyntropin	corticotropin	Sandoz	5	S	21-Feb-2008
N022101	Nexium	esomeprazole magnesium	AstraZeneca	3	P	27-Feb-2008
N022033	Luvox CR	fluvoxamine maleate	Solvay	3	S	28-Feb-2008
N021992	Pristiq	desvenlafaxine succinate	Wyeth	1	S	29-Feb-2008

New Drug Application (NDA) Tentative Approvals under the President's Emergency Plan for AIDS Relief (PEPFAR):

BLA Number	Proprietary Name	Proper Name	Applicant	Review Classification	Approval Date
There were no PEPFAR approvals for February

Biologic License Application (BLA) Approvals:

BLA Number	Proprietary Name	Proper Name	Applicant	Review Classification	Approval Date
125249	Arcalyst	rilonacept	Regeneron	P,O	27-Feb-2008

NDA Chemical Type:
1 -   New molecular entity
2 -   New ester, new salt, or other noncovalent derivative
3 -   New dosage form
4 -   New combination
5 -   New formulation or new manufacturer
7 -   Drug already marketed, but without an approved NDA
8 -  OTC switch

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.
O -  Orphan Designation - Pursuant to Section 526 of the Orphan Drug Act (Public Law 97-414 as amended).

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Last updated: March 13, 2008

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