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