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 September 30, 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;Atrovastatin 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	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	Human Secretin	Human Secretin	Chirhoclin	1	P, O	09-Apr-04
N021629	Apidra	Insulin Glulisine	Aventis Pharms	1	S	16-Apr-04
N021264	Apokyn	Apomorphine Hydrochloride	Bertek	1	P	20-Apr-04
N021574	Fortamet	Metformin Hydrochloride	Andrx	5	S	27-Apr-04
N021640	Vitrase	Ovine Hyaluronidase	Ista Pharms	5	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, O	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	NutreSore	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	11-Aug-04
N021751	Pentetate Zinc Trisodium	Pentetate Zinc Trisodium	Pharma Hameln GmbH	1	P	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

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

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.

Date created: October 25, 2004