CDER Drug and Biologic Approvals for Calendar Year 2004

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FDA/Center for Drug Evaluation and Research

CDER Drug and Biologic Approvals for Calendar Year 2004
Updated through December 31, 2004

All New Drug Application (NDA) Approvals:

NDA Number	Proprietary Name	Established Name	Applicant	Chemical Type	Review Classification	Approval Date
N021604	Children's Elixsure IB	Ibuprofen	Taro Pharms	5	S	07-Jan-04
N021539	Acetadote	Acetylcysteine	Cumberland Pharms	3	P, O	23-Jan-04
N021646	Infuvite Pediatric	Multiple Vitamins	Sabex 2002	5	S	29-Jan-04
N021395	Spiriva Handihaler	Tiotropium Bromide	Boehringer Ingelheim	1	S	30-Jan-04
N021540	Caduet	Amlodipine Besylate; Atorvastatin Calcium	Pfizer	4	S	30-Jan-04
N021625	MVI Adult	Multi-Vitamins	aaiPharma	3	S	30-Jan-04
N021462	Alimta	Pemetrexed Disodium	Eli Lilly	1	P, O	04-Feb-04
N021594	Amiodarone Hydrochloride	Amiodarone Hydrochloride	International Medication Sys	5	S	04-Feb-04
N021644	Clobex	Clobetasol Propionate	Galderma Labs	3	S	05-Feb-04
N021166	Estrogel	Estradiol	Solvay Pharms	3	S	09-Feb-04
N021590	Fazaclo	Clozapine	Alamo Pharms	3	S	10-Feb-04
N021643	MVI Adult	Multi-Vitamins	aaiPharma	3	S	18-Feb-04
N021587	Children's Advil Allergy Sinus	Ibuprofen; Pseudophedrine Hydrochloride; Chlorpheniramine Maleate	Wyeth Cons	3	S	24-Feb-04
N050791	Myfortic	Mycophenolic Acid	Novartis Pharms	2	S	27-Feb-04
N021571	Iquix	Levofloxacin	Santen	3	S	01-Mar-04
N021688	Sensipar	Cinacalcet Hydrochloride	Amgen	1	P, O	08-Mar-04
N021621	Zyrtec	Cetirizine Hydrochloride	Pfizer	3	S	16-Mar-04
N021211	Follistim AQ	Follitropin Beta	Organon	3	S	23-Mar-04
N021765	Gonal-F	Follitropin Alfa	Serono Inc	3	S	25-Mar-04
N021253	Zyprexa IM	Olanzapine	Eli Lilly	3	S	29-Mar-04
N021144	Ketek	Telithromycin	Aventis Pharms	1	S	01-Apr-04
N020784	Nasacort HFA	Triamcinolone Acetonide	Aventis Pharms	3	S	07-Apr-04
N021256	ChiRhoStim	Human Secretin	Chirhoclin	1	P	09-Apr-04
N021629	Apidra	Insulin Glulisine	Aventis Pharms	1	S	16-Apr-04
N021264	Apokyn	Apomorphine Hydrochloride	Bertek	1	P, O	20-Apr-04
N021574	Fortamet	Metformin Hydrochloride	Andrx	5	S	27-Apr-04
N021640	Vitrase	Ovine Hyaluronidase	Ista Pharms	1	P	05-May-04
N021504	Lidosite Topical System	Lidocaine Hydrochloride; Epinephrine	Vyteris	3	S	06-May-04
N021617	Zalkote	Valproate Sodium	Andrx	3	S	06-May-04*
N021443	Enjuvia	Synthetic Conjugated Estrogens, B	Duramed	3	S	10-May-04
N021551	Halflytely and Bisacodyl Bowel Prep Kit	PEG-3350; Sodium Chloride; Sodium Bicarbonate; Potassium Chloride; Bisacodyl	Braintree	3	S	10-May-04
N021433	Flovent HFA	Fluticasone Propionate	GlaxoSmithKline	3	S	14-May-04
N021618	Tindamax	Tinidazole	Presutti Labs	1	S	17-May-04
N021671	Depodur	Morphine Sulfate	Skye Pharma	3	S	18-May-04
N050794	Vidaza	Azacitidine	Pharmion	1	P, O	19-May-04
N021361	Xifaxan	Rifaximin	Salix Pharms	1	S	25-May-04
N021494	Axid	Nizatidine	Reliant Pharma	3	S	25-May-04
N021684	Gonal-F RFF Pen	Follitropin Alfa	Serono Inc	3	S	25-May-04
N021566	Prevacid IV	Lansoprazole	Tap Pharm	3	S	27-May-04
N021595	Sanctura	Trospium Chloride	Indevus	1	S	28-May-04
N021530	Mobic	Meloxicam	Boehringer Ingelheim	3	S	01-Jun-04
N021516	Istalol	Timolol Maleate	Senju	3	S	04-Jun-04
N021667	NutreStore	L-Glutamine	Nutritional Restart	1	S, O	10-Jun-04
N021636	Zegerid	Omeprazole	Santarus	3	S	15-Jun-04
N021369	Codeprex	Codeine Polistirex; Chlorpheniramine Polistirex	Celltech Pharms	3	S	21-Jun-04
N021585	Mucinex D	Guaifenesin; Pseudoephedrine Hydrochloride	Adams	3	S	22-Jun-04
N021512	Loratadine	Loratadine	Perrigo	3	S	24-Jun-04
N050789	Tobramycin	Tobramycin	American Pharm	5	S	13-Jul-04
N021612	Luxacor	Fenofibrate	Cipher	3	S	15-Jul-04*
N021497	Alinia	Nitazoxanide	Romark	3	P	21-Jul-04
N021687	Vytorin	Ezetimibe; Simvastatin	MSP Singapore	4	S	23-Jul-04
N021415	Metvix	Methyl Aminolevulinate	PhotoCure ASA	3	S	27-Jul-04
N021431	Campral	Acamprosate Calcium	Lipha	1	P	29-Jul-04
N050792	Cefotaxime and Dextrose Duplex Container	Cefotaxime Sodium	B Braun	5	S	29-Jul-04
N021652	Epzicom	Abacavir Sulfate; Lamivudine	GlaxoSmithKline	3	S	02-Aug-04
N021752	Truvada	Emtricitabine; Tenofovir Disoproxil Fumarate	Gilead Sciences	4	P	02-Aug-04
N021427	Cymbalta	Duloxetine Hydrochloride	Eli Lilly	1	S	03-Aug-04
N021768	Fludeoxyglucose F18	Fludeoxyglucose F18	Weill Medical College	3	S	05-Aug-04
N021749	Pentetate Calcium Trisodium	Pentetate Calcium Trisodium	Pharma Hameln GmbH	1	P, O	11-Aug-04
N021751	Pentetate Zinc Trisodium	Pentetate Zinc Trisodium	Pharma Hameln GmbH	1	P, O	11-Aug-04
N021633	Femtrace	Estradiol Acetate	Warner Chilcott	3	S	20-Aug-04
N021648	Digoxin	Digoxin	Roxane	7	S	26-Aug-04
N021678	Tequin	Gatifloxacin	Bristol-Myers Squibb	3	S	27-Aug-04
N021698	Zantac	Ranitidine Hydrochloride	Pfizer Consumer Healthcare	3	S	31-Aug-04
N021300	Clarinex	Desloratadine	Schering	3	S	01-Sep-04
N021563	Clarinex	Desloratadine	Schering	3	P	01-Sep-04
N021712	Fluxid	Famotidine	Schwarz Pharma	3	S	24-Sep-04
N021044	Palladone	Hydromorphone Hydrochloride	Purdue Pharma	3	S	24-Sep-04
N021727	Amlexanox	Amlexanox	Access Pharms	3	S	29-Sep-04
N021735	Terconazole	Terconazole	Altana	5	S	01-Oct-04
N021322	Luveris	Lutropin Alfa	Serono Inc	3	S, O	08-Oct-04
N021732	Vantas	Histrelin Acetate	Valera	3	S	12-Oct-04
N021683	Manoplex	Insoluble Prussian Blue	Degussa	5	P	14-Oct-04*
N021719	Aricept	Donepezil Hydrochloride	EISAI Medical	3	S	18-Oct-04
N021720	Aricept	Donepezil Hydrochloride	EISAI Medical	3	S	18-Oct-04
N021704	Allegra-D 24 Hour	Fexofenadine Hydrochloride; Pseudoephedrine Hydrochloride	Aventis Pharms	3	S	19-Oct-04
N021721	Levaquin	Levoflaxin	Ortho McNeil	3	S	21-Oct-04
N050801	Evoclin	Clindamycin Phosphate	Connetics	3	S	22-Oct-04*
N021468	Fosrenol	Lanthanum Carbonate Hydrate	Shire Pharm	1	S	26-Oct-04
N021486	Lidocaine Hydrochloride;Epinephrine	Lidocaine Hydrochloride; Epinephrine	EMPI	4	S	26-Oct-04
N021665	Amphadase	Hyaluronidase	Amphastar Pharm	1	P	26-Oct-04
N021736	Xamlom	Amlodipine	Ranbaxy Res	3	S	28-Oct-04*
N021457	Albuterol Sulfate	Albuterol Sulfate	Ivax Res	3	S	29-Oct-04
N021663	Menopur	Menotropins	Ferring	3	S	29-Oct-04
N021656	Tricor	Fenofibrate	Abbott	3	S	05-Nov-04
N021654	Omacor	Omega-3-acid Ethyl Esters	Ross Prods	1	S	10-Nov-04
N021527	Atrovent HFA	Ipratropium Bromide	Boehringer Ingelheim	3	S	17-Nov-04
N021743	Tarceva	Erlotinib Hydrochloride	OSI Pharms	1	P	18-Nov-04
N021518	VESIcare	Solifenacin Succinate	Yamanouchi	1	S	19-Nov-04
N021357	Multihance	Gadobenate Dimeglumine	Bracco	1	S	23-Nov-04
N021358	Multihance Multipack	Gadobenate Dimeglumine	Bracco	3	S	23-Nov-04
N021378	Combunox	Ibuprofen; Oxycodone Hydrochloride	Forest Labs	4	S	26-Nov-04
N021695	Antara	Fenofibrate	Reliant Pharms	3	S	30-Nov-04
N050793	Clindesse	Clindamycin Phosphate	KV Pharm	5	S	30-Nov-04
N021786	Kelacal	Pentetate Calcium Trisodium	CIS	5	P	01-Dec-04*
N021787	Kelazin	Pentetate Zinc Trisodium	CIS	5	P	01-Dec-04*
N021713	Abilify	Aripiprazole	Otsuka America	3	S	10-Dec-04
N021731	Eligard	Leuprolide Acetate	Atrix	3	S	14-Dec-04
N050804	Zylet	Loteprednol Etabonate; Tobramycin	Bausch and Lomb	4	S	14-Dec-04
N021476	Lunesta	Eszopicline	Sepracor	1	S	15-Dec-04
N021670	Vision Blue	Trypan Blue	Dorc International BV	1	P	16-Dec-04
N021583	Depo-SubQ Provera 104	Medroxyprogesterone Acetate	Pfizer	3	S	17-Dec-04
N021756	Macugen	Pegaptanib Sodium	Eyetech Pharms	1	P	17-Dec-04
N021785	Invirase	Saquinavir Mesylate	Roche	3	P	17-Dec-04
N021609	Enjuvia	Synthetic Conjugated Estrogens, B	Duramed Pharms	3	S	20-Dec-04
N021706	Omeprazole	Omeprazole	Santarus	3	S	21-Dec-04
N021513	Enablex	Darifenacin Hydrobromide	Novartis	1	S	22-Dec-04
N021545	Olopatadine Hydrochloride	Olopatadine Hydrochloride	Alcon	3	S	22-Dec-04
N021060	Prialt	Ziconotide	Elan Pharms	1	P	28-Dec-04
N021673	Clolar	Clofarabine	Genzyme	1	P, O	28-Dec-04
N021779	Ventavis	Iloprost	Cotherix	1	P, O	29-Dec-04
N021446	Lyrica	Pregabalin	Pfizer	1	P	30-Dec-04

All Biologic License Application (BLA) Approvals:

BLA Number	Proprietary Name	Proper Name	Applicant	Review Classification	Approval Date
BL125084	Erbitux	Cetuximab	ImClone Systems	P	12-Feb-04
BL125085	Avastin	Bevacizumab	Genentech	P	26-Feb-04
BL125083	Pegasys Copegus Combination Pack	Peginterferon alfa-2a co-packaged with Ribavirin	Hoffmann-La Roche	S	04-Jun-04
BL103928	NeutroSpec	Technetium 99m Tc Fanolesomab	Palatin Technologies	S	02-Jul-04
BL125104	Tysabri	Natalizumab	Biogen Idec Inc.	P	23-Nov-04
BL125103	Kepivance	Palifermin	Amgen, Inc.	P	15-Dec-04

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

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).

* NDA 21617, Zalkote was tentatively approved on May 6, 2004.

* NDA 21612, Luxacor was tentatively approved on July 15, 2004.

* NDA 21683, Manoplex was tentatively approved on October 14, 2004.

* NDA 21736, Xamlom was tentatively approved on October 28, 2004.

* NDA 21786, Kelacal was tentatively approved on December 1, 2004.

* NDA 21787, Kelazin was tentatively approved on December 1, 2004.

* NDA number for Evoclin was administratively changed from 21709 to 50801.

To access approval letters, labels, and review packages, go to

Date created: March 5, 2004; updated October 11, 2007