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U.S. Department of Health and Human Services

Drugs

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Priority NDA and BLA Approvals in 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).