CDER Drug and Biologic Approvals for Calendar Year 2006
Updated through December 31, 2006

New Drug Application (NDA) Approvals:

NDA Number	Proprietary Name	Established Name	Applicant	Chemical Type	Review Classification	Approval Date
N021858	Boniva	ibandronate sodium	Hoffmann-La Roche	3	S	06-Jan-2006
N021852	Taclonex	calcipotriene; betamethasone dipropionate	LEO Pharma	3	S	09-Jan-2006
N021612	Lipofen	fenofibrate	Cipher	3	S	11-Jan-2006
N021812	Men's Rogaine	minoxidil	Pharmacia and Upjohn	3	S	20-Jan-2006
N021938	Sutent	sunitinib malate	Pfizer	1	P	26-Jan-2006
N021247	Aerospan	flunisolide HFA	Forest Labs	3	S	27-Jan-2006
N021526	Ranexa	ranolazine	CV Therapeutics	1	S	27-Jan-2006
N021868	Exubera	insulin [rDNA Origin]	Pfizer	3	S	27-Jan-2006
N021908	Amitiza	lubiprostone	Sucampo	1	S	31-Jan-2006
N021313	Clarinex-D 12 Hour	desloratadine; pseudoephedrine sulfate	Schering	5	S	01-Feb-2006
N021026	Vusion	miconazole nitrate	Barrier Therapeutics	3	S	16-Feb-2006
N021920	naproxen sodium	naproxen sodium	Banner Pharmacaps	3	S	17-Feb-2006
N021871	Loestrin 24 Fe	norethindrone acetate; ethinyl estradiol; ferrous fumarate	Warner Chilcott	3	S	17-Feb-2006
N021632	Eraxis	anidulafungin	Vicuron	1	S	17-Feb-2006
N021849	Zegerid	omeprazole; sodium bicarbonate	Santarus	4	S	27-Feb-2006
N021336	Emsam	selegiline hydrochloride	Somerset Pharms	3	S	27-Feb-2006
N021676	YAZ	drospirenone; ethinyl estradiol	Berlex	2	S	16-Mar-2006
N021892	OsmoPrep	sodium phosphate monobasic monohydrate; sodium phosphate dibasic anhydrous	Salix	3	S	16-Mar-2006
N021850	Zegerid with Magnesium Hydroxide	magnesium hydroxide; omeprazole; sodium bicarbonate	Santarus	3,4	S	24-Mar-2006
N021980	Fluorescite	fluorescein	Alcon Research	5	P	28-Mar-2006
N021483	Geodon	ziprasidone hydrochloride	Pfizer	3	S	29-Mar-2006
N022010	Septocaine	articaine hydrochloride; epinephrine	Deproco	5	S	30-Mar-2006
N021514	Daytrana	methylphenidate	Noven Pharms	2,3	S	06-Apr-2006
N021897	Vivitrol	naltrexone	Alkermes	3	P	13-Apr-2006
N021903	NeoProfen	ibuprofen lysine	Farmacon-IL, LLC	2	P, O	13-Apr-2006
N021790	Dacogen	decitabine	MGI Pharma	1	S, O	02-May-2006
N050808	Solodyn	minocycline hydrochloride	Medicis	3	S	08-May-2006
N021928	Chantix	varenicline	Pfizer	1	P	10-May-2006
N021641	Azilect	rasagiline mesylate	TEVA	1	S	16-May-2006
N021860	Sarafem	fluoxetine hydrochloride	Warner Chilcott	3	S	19-May-2006
N021338	Ionsys	fentanyl iontophoretic transdermal system	ALZA	3	S	22-May-2006
N021764	brimonidine tartrate	brimonidine tartrate	Alcon	5	S	22-May-2006
N021840	Seasonique	levonorgestrel/ethinyl estradiol and ethinyl estradiol	Duramed	3	S	25-May-2006
N050805	Oracea	doxycycline	CollaGenex	3	S	26-May-2006
N021426	Omnitrope	somatropin [rDNA origin]	Sandoz	5	S	30-May-2006
N021959	Orapred ODT	prednisolone sodium phosphate	BioMarin	3	S	01-Jun-2006
N021729	Abilify Discmelt	Aripiprazole	Otsuka	3	S	07-Jun-2006
N021254	Advair HFA	Fluticasone propionate and salmeterol xinafoate	GlaxoSmithKline	3	S	08-Jun-2006
N021479	Zelapar	selegiline hydrochloride	Valeant	3	S	14-Jun-2006
N021610	Opana	oxymorphone hydrochloride	Endo	3	S	22-Jun-2006
N021611	Opana	oxymorphone hydrochloride	Endo	3	S	22-Jun-2006
N021976	Prezista	darunavir	Tibotec	1	P	23-Jun-2006
N021986	Sprycel	dasatinib	Bristol-Myers Squibb	1	P, O	28-Jun-2006
N021717	lidocaine; tetracaine	lidocaine; tetracaine	Zars	4	S	29-Jun-2006
N021937	Atripla	efavirenz; emtricitabine; tenofovir disoproxil fumarate	Gilead Sciences	4	P	12-Jul-2006
N021949	budesonide	budesonide	AstraZeneca	5	S	12-Jul-2006
N021529	Implanon	etonogestrel	Organon USA	3	S	17-Jul-2006
N021502	Anthelios SX	avobenzone; ecamsule; octocrylene	L'Oreal	1,4	S	21-Jul-2006
N021929	Symbicort	budesonide; formoterol fumarate dihydrate	AstraZeneca	4	S	21-Jul-2006
N021958	Lamisil AT	terbinafine	Novartis	8	S	24-Jul-2006
N021910	Normocarb HF	sodium chloride; magnesium chloride hexahydrate; sodium bicarbonate	Dialysis Solutions	3	S, O	26-Jul-2006
N021569	Sodium Chloride	sodium chloride	Tyco Healthcare Mallinckrodt	5	S	27-Jul-2006
N021925	Duetact	pioglitazone hydrochloride;glimepiride	Takeda Global	4	S	28-Jul-2006
N021946	Xolegel	ketoconazole	Barrier Therapeutics	3	S	28-Jul-2006
N021872	Keppra	levetiracetam	UCB	3	S	31-Jul-2006
N021881	Moviprep	PEG 3350; sodium sulfate; sodium chloride; potassium chloride; sodium ascorbate; ascorbic acid	Norgine	3	S	02-Aug-2006
N021891	Children's Claritin	loratadine	Schering-Plough	3	S	23-Aug-2006
N021956	Dutoprol	metoprolol succinate; hydrochlorothiazide	AstraZeneca	4	S	28-Aug-2006
N022003	Noxafil	posaconazole	Schering	1	P	15-Sep-2006
N050807	epirubicin hydrochloride	epirubicin hydrochloride	Mayne	5	S	15-Sep-2006
N021978	Verdeso	desonide	Connetics	3	S	19-Sep-2006
N021866	Abilify	aripiprazole	Otsuka Maryland Research	3	S	20-Sep-2006
N021412	zolpidem tartrate	zolpidem tartrate	Biovail	3	S	21-Sep-2006
N021994	Travatan Z	travoprost	Alcon	3	S	21-Sep-2006
N021947	Fentora	fentanyl buccal	Cephalon	3	S	25-Sep-2006
N021983	Duodote	atropine;pralidoxime chloride	Meidian	5	P	28-Sep-2006
N050786	Pylera	biskalcitrate;metronidazole;tetracycline hydrochloride	Axcan Scandipharm	1,4	S	28-Sep-2006
N021586	Duraprep	iodine;isopropyl alcohol	3M Health	4	S	29-Sep-2006
N021501	Capital Soleil 15; UV Expert 15	avobenzone;ecamsule;octocrylene	L'Oreal	5	S	02-Oct-2006
N021471	UV Protective Suncare; Capitol Soleil 20; Anthelios 20; UV Expert 20	avobenzone;ecamsule;octocrylene;titanium dioxide	L'Oreal	4	S	05-Oct-2006
N022015	Miralax	polyethylene glycol 3350	Braintree	8	S	06-Oct-2006
N021991	Zolinza	vorinostat	Merck	1	P,O	06-Oct-2006
N021912	Brovana	arformoterol tartrate	Sepracor	3	S	06-Oct-2006
N021924	Tirosint	levothyroxine sodium	Institute Biochimique SA (IBSA)	3	S	13-Oct-2006
N021995	Januvia	sitagliptin phosphate	Merck	1	S	16-Oct-2006
N021963	Allegra	fexofenadine hydrochloride	Sanofi Aventis	3	S	16-Oct-2006
N022012	Coreg CR	carvedilol phosphate	GlaxoSmithKline	2	S	20-Oct-2006
N022004	Omnaris	ciclesonide	Altana	1	S	20-Oct-2006
N021957	Nexium	esomeprazole magnesium	AstraZeneca	3	S	20-Oct-2006
N021844	Desonate	desonide	Dow Pharmaceutical Sciences	3	S	20-Oct-2006
N022011	Tyzeka	telbivudine	Idenix	1	S	25-Oct-2006
N021703	Prismasol	sodium bicarbonate;sodium chloride;potassium chloride;magnesium chloride;lactic acid;dextrose;calcium chloride	Gambro Renal Products	3	S	25-Oct-2006
N021902	Veregen	kunecatechins	MediGene	1	S	31-Oct-2006
N021780	NitroMist	nitroglycerin	NovaDel	3	S	02-Nov-2006
N050802	Ziana	clindamycin phosphate;tretinoin	Dow Pharmaceutical Sciences	4	S	07-Nov-2006
N021996	Alaway	ketotifen fumarate	Alimera Sciences	3	S	01-Dec-2006
N021993	Claritin RediTabs	loratadine	Schering-Plough	5	S	12-Dec-2006
N021592	Foradil Certihaler	formoterol fumarate	Novartis	3	S	15-Dec-2006
N021813	Elestrin	estradiol	BioSante	5	S	15-Dec-2006
N022041	Cyanokit	hydroxocobalamin	EMD Pharm	3	P,O	15-Dec-2006
N021999	Invega	paliperidone	Janssen, L.P.	1	S	19-Dec-2006
N050809	Azithromycin	azithromycin	Sicor	3	S	19-Dec-2006
N021915	Ondansetron	ondansetron sodium chloride	Baxter Healthcare	3	S	27-Dec-2006

N021612 Liopofen was tentatively approved on 7/15/2004
N021764 Brimonidine Tartrate was tentatively approved on 2/28/2005 
N050807 Epirubicin was tentatively approved on 8/17/2006
N021915 Ondansetron was tentatively approved on 5/26/2006

New Drug Application (NDA) Tentative Approvals

NDA Number	Proprietary Name	Established Name	Applicant	Chemical Type	Review Classification	Approval Date
N021714	amlodipine maleate;benazepril hydrochloride	amlodipine maleate;benazepril hydrochloride	Reddy's Lab	4	S	15-Sep-2006
N021990	Exforge	amlodipine besylate	Novartis	4	S	21-Dec-2006

N021714 amlodipine maleate;benazepril hydrochloride was tentatively approved on 9/15/2006
N021990 Exforge was tentatively approved on 12/21/2006

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

NDA Number	Proprietary Name	Established Name	Applicant	Chemical Type	Review Classification	Approval Date
N021943	efavirenz;lamivudine;zidovudine	efavirenz;lamivudine;zidovudine	Aurbindo	4	P	06-Mar-06
N021939	lamivudine;zidovudine; nevirapine	lamivudine;zidovudine;nevirapine	Aurobindo	4	P	30-Jun-2006
N021944	lamivudine;zidovudine;abacavir sulfate	abacavir sulfate;lamivudine;zidovudine	Aurobindo	4	P	26-Jul-2006
N022018	lamivudine;zidovudine;	lamivudine;zidovudine;	Pharmacare	4	P	23-Aug-2006
N021969	lamivudine;stavudine;nevirapine	lamivudine;stavudine;nevirapine	Cipla Limited	4	P	17-Nov-2006

N021943 lamivudine 150mg/zidovudine 300mg Fixed-Dose Tablets co-packaged with efavirenz 600mg Tablets was tentatively approved on 3/06/2006 under PEPFAR.
N021939 lamivudine 150mg/zidovudine 300mg/nevirapine 200mg Tablets was tentatively approved on 6/30/2006 under PEPFAR.
N021944 lamivudine 150mg/zidovudine 300mg/Co-Packaged with abacavir sulfate 300mg Tablets was tentatively approved on 07/26/2006 under PEPFAR.
N022018 lamivudine 150mg/zidovudine 300mg Tablets was tentatively approved on 08/23/2006 under PEPFAR.
N021969 lamivudine 150mg/stavudine 30mg/nevirapine 200mg and  lamivudine 150mg/stavudine 40mg/nevirapine 200mg Tablets was tentatively approved on 11/17/2006 under PEPFAR.

Biologic License Application (BLA) Approvals:

BLA Number	Proprietary Name	Proper Name	Applicant	Review Classification	Approval Date
BL125141	Myozyme	alglucosidase alfa	Genzyme	P, O	28-Apr-2006
BL125156	Lucentis	ranibizumab	Genentech	P	30-Jun-2006
BL125151	Elaprase	idursulfase	Shire Human Genetic Therapies	P, O	24-Jul-2006
BL125147	Vectibix	panitumumab	Amgen	P	27-Sep-2006

 

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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