CDER Drug and Biologic Approvals for Calendar Year 2005

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FDA/Center for Drug Evaluation and Research

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

Date created: March 7, 2005; updated October 25, 2006