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CDER
Drug and Biologic Approvals for Calendar Year 2005
Updated
through December 31, 2005
All New Drug Application
(NDA) Approvals:
NDA Number |
Proprietary
Name |
Established
Name |
Applicant |
Chemical
Type |
Review
Classification |
Approval
Date |
N021660 |
Abraxane |
Paclitaxel Protein-Bound
Particles |
American BioScience |
5 |
S |
07-Jan-05 |
N021726 |
Niravam |
Alprazolam |
Schwarz Pharma |
5 |
S |
19-Jan-05 |
N021841 |
Lamivudine; Zidovudine; Nevirapine |
Lamivudine; Zidovudine; Nevirapine |
Pharmacare |
4 |
P |
24-Jan-05* |
N021642 |
Nascobal |
Cyanocobalamin |
Nastech Pharma |
3 |
S |
31-Jan-05 |
N021759 |
Eloxatin |
Oxaliplatin |
Sanofi-Synthelabo |
5 |
S |
31-Jan-05 |
N021758 |
Vanos |
Fluocinonide |
Medicis Pharma |
3 |
S |
11-Feb-05 |
N020645 |
Ammonul |
Sodium Benzoate; Sodium
Phenylacetate |
Ucyclyd Pharma |
5 |
P, O |
17-Feb-05 |
N021269 |
Cardura XL |
Doxazosin Mesylate |
Pfizer |
3 |
S |
22-Feb-05 |
N021764 |
Brimonidine Tartrate |
Brimonidine Tartrate |
Alcon |
3 |
S |
28-Feb-05* |
N021605 |
Clarinex
D24 |
Desloratadine; Pseudoephedrine Sulfate |
Schering |
3 |
S |
03-Mar-05 |
N021730 |
Xopenex
HFA |
Levalbuterol Tartrate |
Sepracor |
3 |
S |
11-Mar-05 |
N021332 |
Symlin |
Pramlintide Acetate |
Amylin |
1 |
S |
16-Mar-05 |
N021506 |
Mycamine |
Micafungin
Sodium |
Fujisawa |
1 |
P |
16-Mar-05 |
N021664 |
Xibrom |
Bromfenac
Sodium |
ISTA
Pharms |
3 |
S |
24-Mar-05 |
N021584 |
Depo-SubQ
Provera 104 |
Medroxyprogesterone Acetate |
Pfizer |
5 |
S |
25-Mar-05 |
N021797 |
Baraclude |
Entecavir |
Bristol
Myers Squibb |
1 |
P |
29-Mar-05 |
N021798 |
Baraclude |
Entecavir |
Bristol
Myers Squibb |
3 |
P |
29-Mar-05 |
N021067 |
Asmanex
Twisthaler |
Mometasone
Furoate |
Schering |
3 |
S |
30-Mar-05 |
N021152 |
Cutivate |
Fluticasone Propionate |
GlaxoSmithKline |
3 |
S |
31-Mar-05 |
N021689 |
Nexium IV |
Esomeprazole Sodium |
AstraZeneca |
3 |
S |
31-Mar-05 |
N021615 |
Razadyne ER |
Galantamine Hydrobromide |
Johnson and Johnson |
3 |
S |
01-Apr-05 |
N021762 |
Fosamax
Plus D |
Alendronate Sodium; Vitamin D3 |
Merck |
4 |
S |
07-Apr-05 |
N021737 |
Retisert |
Fluocinolone Acetonide |
Bausch and
Lomb |
3 |
P, O |
08-Apr-05 |
N021627 |
Namenda |
Memantine
Hydrochloride |
Forest
Labs |
3 |
S |
18-Apr-05 |
N050796 |
Ceftriaxone Sodium; Dextrose in Duplex Container |
Ceftriaxone Sodium; Dextrose |
B Braun |
5 |
S |
20-Apr-05 |
N021669 |
Chlorhexidine Gluconate Cloth |
Chlorhexidine Gluconate |
Sage Prods |
3 |
S |
25-Apr-05 |
N021773 |
Byetta |
Exenatide |
Amylin |
1 |
S |
28-Apr-05 |
N021693 |
Tramadol
Hydrochloride |
Tramadol
Hydrochloride |
Biovail
Labs |
3 |
S |
05-May-05 |
N050795 |
Doryx |
Doxycyclin
Hyclate |
Faulding
Pharms |
3 |
S |
06-May-05 |
N021350 |
Triglide |
Fenofibrate |
Skye
Pharma |
3 |
S |
07-May-05 |
N021744 |
Proquin XR |
Ciprofloxacin Hydrochloride |
Depomed |
2 |
S |
19-May-05 |
N021806 |
Metronidazole |
Metronidazole |
Teva
Pharms |
5 |
S |
20-May-05 |
N021412 |
Zolpidem
Tartrate |
Zolpidem
Tartrate |
Biovail |
3 |
S |
26-May-05* |
N021606 |
Zemplar |
Paricalcitol |
Abbott
Labs |
3 |
S |
26-May-05 |
N021802 |
Focalin XR |
Dexmethylphenidate Hydrochloride |
Novartis
Pharms |
3 |
S |
26-May-05 |
N021524 |
Chlorascrub |
Chlorhexidine Gluconate; Isopropyl Alcohol |
Nice-Pak |
3 |
S |
03-Jun-05 |
N021748 |
Glumetza |
Metformin
Hydrochloride |
Biovail |
5 |
S |
03-Jun-05 |
N021845 |
Revatio |
Sildenafil
Citrate |
Pfizer |
5 |
P |
03-Jun-05 |
N021793 |
Metoclopramide |
Metoclopramide |
Schwarz
Pharma |
3 |
S |
10-Jun-05 |
N050797 |
Zmax |
Azithromycin |
Pfizer |
3 |
S |
10-Jun-05 |
N021821 |
Tygacil |
Tigecycline |
Wyeth
Pharms |
1 |
P |
15-Jun-05 |
N021536 |
Levemir |
Insulin
Detemir |
Novo Nordisk |
1 |
S |
16-Jun-05 |
N021814 |
Aptivus |
Tipranavir |
Boehringer
Ingelheim |
1 |
P |
22-Jun-05 |
N020727 |
Bidil |
Hydralazine Hydrochloride; Isosorbide Dinitrate |
Nitromed |
4 |
S |
23-Jun-05 |
N021623 |
Synera |
Lidocaine;
Tetracaine |
Zars |
4 |
S |
23-Jun-05 |
N021789 |
Metrogel |
Metronidazole |
Dow Pharm |
3 |
S |
30-Jun-05 |
N021832 |
Levofloxacin |
Levofloxacin |
Sicor Pharms |
3 |
S |
30-Jun-05* |
N021778 |
Megace ES |
Megestrol
Acetate |
Par Pharm |
5 |
S |
05-Jul-05 |
N021794 |
Aczone |
Dapsone |
QLT USA |
3 |
S |
07-Jul-05 |
N021782 |
Rozerem |
Ramelteon |
Takeda Global |
1 |
S |
22-Jul-05 |
N021855 |
Loperamide Hydrochloride |
Loperamide Hydrochloride |
Banner Pharmacaps |
3 |
S |
4-Aug-05 |
N021823 |
Actonel With Calcium |
Risedronate Sodium; Calcium
Carbonate |
Proctor and Gamble |
4 |
S |
12-Aug-05 |
N021799 |
Quinine Sulfate |
Quinine Sulfate |
Mutual |
5 |
S, O |
12-Aug-05 |
N021406 |
Fortical |
Calcitonin-Salmon [rDNA origin] |
Unigene |
3 |
S |
12-Aug-05 |
N021862 |
Nevanac |
Nepafenac |
Alcon |
1 |
P |
19-Aug-05 |
N021770 |
Alphagan P |
Brimonidine Tartrate |
Allergan |
3 |
S |
19-Aug-05 |
N021273 |
Follistim AQ |
Follitropin Beta |
Organon |
3 |
S |
26-Aug-05 |
N021842 |
Actoplus Met |
Metformin Hydrochloride;
Pioglitazone Hydrochloride |
Takeda |
4 |
S |
29-Aug-05 |
N021839 |
Increlex |
Mecasermin [rDNA origin] |
Tercica |
1 |
P, O |
30-Aug-05 |
N021774 |
Ambien CR |
Zolpidem Tartrate |
Sanofi
Synthelabo |
3 |
S |
02-Sep-05 |
N021692 |
Tramadol Hydrochloride |
Tramadol Hydrochloride |
Biovail |
5 |
S |
08-Sep-05 |
N021355 |
Angeliq |
Drospirenone; 17B-Estradiol |
Berlex |
4 |
S |
28-Sep-05 |
N021896 |
Emtriva |
Emtricitabine |
Gilead |
3 |
P |
28-Sep-05 |
N021734 |
Loratadine |
Loratadine |
Taro Pharm |
3 |
S |
04-Oct-05 |
N021716 |
Hydase |
Hyaluronidase |
PrimaPharm |
1 |
P |
25-Oct-05 |
N021835 |
Clobex |
Clobetasol Propionate |
Dow Pharm |
3 |
S |
27-Oct-05 |
N021877 |
Arranon |
Nelarabine |
GlaxoSmithKline |
1 |
P, O |
28-Oct-05 |
N021906 |
Kaletra |
Lopinavir; Ritonavir |
Abbott Labs |
3 |
P |
28-Oct-05 |
N021807 |
Soltamox |
Tamoxifen Citrate |
Savient Pharms |
3 |
S |
29-Oct-05 |
N021882 |
Exjade |
Deferasirox |
Novartis |
1 |
P, O |
02-Nov-05 |
N021700 |
Avandaryl |
Rosiglitazone Maleate; Glimepride |
SB
Pharmco |
4 |
S |
23-Nov-05 |
N021859 |
Hylenex Recombinant |
Hyaluronidase Human |
Halozyme |
1 |
P |
02-Dec-05 |
N021884 |
Iplex |
Mecasermin Rinfabate [rDNA
Origin] |
Insmed |
1, 4 |
P, O |
12-Dec-05 |
N021763 |
Citalopram Hydrobromide |
Citalopram Hydrobromide |
Biovail |
3 |
S |
20-Dec-05 |
N021923 |
Nexavar |
Sorafenib Tosylate |
Bayer |
1 |
P, O |
20-Dec-05 |
N021393 |
Advil PM Liqui-Gels |
Ibuprofen; Diphenhydramine
Citrate |
Wyeth |
4 |
S |
21-Dec-05 |
N021394 |
Advil PM Caplets |
Ibuprofen; Diphenhydramine
Citrate |
Wyeth |
4 |
S |
21-Dec-05 |
N021880 |
Revlimid |
Lenalidomide |
Celgene |
1 |
P, O |
27-Dec-05 |
N021697 |
Vaprisol |
Conivaptan Hydrochloride |
Astellas |
1 |
S |
29-Dec-05 |
All Biologic License Application (BLA) Approvals:
BLA Number |
Proprietary
Name |
Proper
Name |
Applicant |
Review Classification |
Approval
Date |
BL125117 |
Naglazyme |
Galsulfase |
Biomarin Pharmaceutical Inc. |
P, O |
31-May-05 |
BL125118 |
Orencia |
Abatacept |
Bristol-Myers Squibb |
P |
23-Dec-05 |
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 21841, Lamivudine;
Zidovudine; Nevirapine Co-Packaged was tentatively approved
on January 24, 2005 under the President's Emergency Plan
for Aids Relief (PEPFAR).
*
NDA 21764, Brimonidine Tartrate
was tentatively approved on February 28, 2005.
* NDA 21412, Zolpidem Tartrate was
tentatively approved on May 26, 2005.
* NDA 21832,
Levofloxacin
was
tentatively approved on June 30, 2005.
To access
approval letters, labels, and review packages, go to
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Date created: March 7, 2005; updated
October 25, 2006 |
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