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 |
|
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 |
|
1 |
P |
29-Mar-05 |
|
N021798 |
Baraclude |
Entecavir |
|
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 |
|
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
|
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 |
|
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.