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 
