CDER Priority Drug and Biologic Approvals in Calendar Year 2007

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FDA/Center for Drug Evaluation and Research

CDER Priority Drug and Biologic Approvals in Calendar Year 2007
Updated through December 31, 2007

Priority New Drug Application (NDA) Approvals:

NDA Number	Proprietary Name	Established Name	Applicant	Chemical Type	Review Classification	Approval Date	Indication
N022059	Tykerb	lapatinib	GlaxoSmithKline	1	P	13-Mar-07	Provides for the treatment of patients with advanced or metastatic breast cancer whose tumors over-express HER2 (ErbB2) and who have received prior therapy including and anthracycline, a taxane and trastuzumab.
N021817	Reclast	zoledronic acid	Novartis	3	P	16-Apr-2007	Provides for the treatment of Paget's disease of bone.
N022088	Torisel	temsirolimus	Wyeth	1	P,O	30-May-2007	Provides for the treatment of advanced renal cell carcinoma.
N022116	Lexiva	fosamprenavir calcium	GlaxoSmithKline	3	P	14-Jun-2007	Provides for the treatment of HIV infection.
N022081	Letairis	ambrisentan	Gilead Sciences	1	P,O	15-Jun-2007	Provides for the treatment of pulmonary arterial hypertension (WHO Group 1) in patients with WHO class II or III symptoms to improve exercise capacity and delay clinical worsening.
N022128	Selzentry	maraviroc	Pfizer	1	P	06-Aug-2007	Provides for the treatment of patients infected with CCR5-tropic HIV-1.
N022025	Totect	dexrazoxane	Alba BioPharm	5	P	06-Sep-2007	Provides for the treatment of extravasation resulting from IV anthracycline chemotherapy.
N020981	Hycamtin	topotecan	GlaxoSmithKline	3	P	11-Oct-2007	Provides for the treatment of relapsed small cell lung cancer in patients with prior complete or partial response and who are at least 45 days from the end of first-line chemotherapy.
N022145	Isentress	raltegravir pottassium	Merck	1	P	12-Oct-2007	Provides in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-experienced adult patients who have evidence of viral replication and HIV-1 strains resistant to multiple antiretroviral agents.
N022065	Ixempra	ixabepilone	Bristol-Myers Squibb	1	P	16-Oct-2007	Provides in combination with capecitabine for the treatment of patients with metastatic or locally advanced breast cancer resistant to treatment with an anthracycline and a taxane, or whose cancer is taxane resistant and for whom further anthracycline therapy is contraindicated. The new drug also provides as monotherapy for the treatment of matastatic or locally advanced breast cancer in patients whose tumors are resistant or refractory to anthracyclines, taxanes, and capecitabine.
N022048	Triesence	triamcinolone acetonide	Alcon	3	P	29-Nov-2007	Provides for the treatment of the following ophthalmic diseases: sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteriods. Also, is indicated for visualization during vitrectomy.
N022181	Kuvan	sapropterin dihydrochloride	BioMarin	1	P,O	13-Dec-2007	Provides for the reduction of blood phenylalanine (Phe) levels in patients with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU).

New Drug Application (NDA) Tentative Approvals under the President's Emergency Plan for AIDS Relief (PEPFAR):

NDA Number	Proper Name	Established Name	Applicant	Chemical Type	Review Classification	Approval Date	Indication
N021974	lamivudine; stavudine	lamivudine; stavudine	Cipla Limited	4	P	19-Jan-2007	Provides in combination with other antiretroviral agents for the treatment of HIV-1 infection.
N021939	lamivudine; zidovudine; nevirapine	lamivudine; zidovudine; nevirapine	Aurobindo	4	P	29-Jan-2007	Provides in combination with other antiretroviral agents for the treatment of HIV-1 infection.
N021971	lamivudine; zidovudine; nevirapine	lamivudine; zidovudine; nevirapine	Cipla Limited	4	P	31-Jan-2007	Provides in combination with other antiretroviral agents for the treatment of HIV-1 infection.
N021988	lamivudine; zidovudine; nevirapine	lamivudine; zidovudine; nevirapine	Strides Arcolab	4	P	02-Mar-2007	Provides in combination with other antiretroviral agents for the treatment of HIV-1 infection.
N021838	stavudine; lamivudine	stavudine; lamivudine	Strides Arcolab	4	P	13-Mar-2007	Provides in combination with other antiretroviral agents for the treatment of HIV-1 infection.
N021854	stavudine; lamivudine; nevirapine	stavudine; lamivudine; nevirapine	Strides Arcolab	4	P	13-Mar-2007	Provides in combination with other antiretroviral agents for the treatment of HIV-1 infection.
N022096	lamivudine; zidovudine; efavirenz	lamivudine; zidovudine; efavirenz	Strides Arcolab	3	P	01-Jun-2007	Provides in combination with other antiretroviral agents for the treatment of HIV-1 infection.
N022097	lamivudine; stavidine; efavirenz	lamivudine; stavidine; efavirenz	Strides Arcolab	3	P	01-Jun-2007	Provides in combination with other antiretroviral agents for the treatment of HIV-1 infection.
N021972	lamivudine; stavudine; nevirapine	lamivudine; stavudine; nevirapine	Cipla Limited	3,4	P	13-Aug-2007	Provides for use alone as a complete regimen or in combination with other antiretroviral agents for the treatment of HIV-1 infection.
N022085	lamivudine; stavudine	lamivudine; stavudine;	Matrix	4	P	02-Nov-2007	Provides for use alone as in combination with other antiretroviral agents for the treatment of HIV-1 infection.

N021974 lamivudine 150mg/stavudine 30mg and lamivudine 150mg/stavudine 40mg Tablets was tentatively approved on 01/19/2007 under PEPFAR.
N021988 lamivudine 150mg/zidovudine 300mg/nevirapine 200mg Tablets was tentatively approved on 01/29/2007 under PEPFAR.
N021971 lamivudine 150mg/zidovudine 300mg/nevirapine 200mg Tablets was tentatively approved on 01/31/2007 under PEPFAR.
N021988 lamivudine 300mg/zidovudine 150mg/nevirapine 200mg Tablets was tentatively approved on 03/02/2007 under PEPFAR.
N021838 stavudine 40mg/lamivudine 150mg Tablets was tentatively approved on 03/13/2007 under PEPFAR.
N021854 stavudine 40mg/lamivudine 150mg/nevirapine 200mg Tablets was tentatively approved on 03/13/2007 under PEPFAR.
N022096 lamivudine 150mg/zidovudine 300mg/efavirenz 600mg Tablets was tentatively approved on 06/01/2007 under PEPFAR.
N022097 lamivudine 150mg/stavidine 40mg/efavirenz 600mg Tablets was tentatively approved on 06/01/2007 under PEPFAR.
N021972 lamivudine 30mg/stavidine 6mg/nevirapine 50mg Tablets was tentatively approved on 08/13/2007 under PEPFAR.
N022145 Isentress 400 mg Tablets was approved on 10/12/2007 under PEPFAR.
N022085 lamivudine 150mg/stavidine 30mg Tablets was tentatively approved on 11/02/2007 under PEPFAR.

Priority Biologic License Application (BLA) Approvals:

BLA Number	Proprietary Name	Proper Name	Applicant	Review Classification	Approval Date	Indication
BL125166	Soliris	eculizumab	Alexion	P,O	16-Mar-2007	Provides for the treatment of paroxysmal nocturnal hemoglobinuria to reduce hemolysis.

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.
O - Orphan Designation - Pursuant to Section 526 of the Orphan Drug Act (Public Law 97-414 as amended).

To access approval letters, labels, and review packages, go to

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Last updated: August 6, 2008