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U.S. Department of Health and Human Services

Drugs

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Priority NDA and BLA Approvals in 2006

   

Priority New Drug Application (NDA) Approvals:

NDA Number Proprietary Name Established Name Applicant Chemical Type Review Classification Approval Date Indication
N021938 Sutent sunitinib malate Pfizer 1 P 26-Jan-06 Provides for the treatment of gastrointestinal stromal tumor after disease progression on or intolerance to imatinib mesylate and for the treatment of advanced renal cell carcinoma. .
N021980 Fluorescite fluorescein Alcon Research 5 P 28-Mar-06 Provides for the use in diagnostic fluoresceine angiography or angioscopy of the retina and iris vasculature.
N021897 Vivitrol naltrexone Alkermes 3 P 13-Apr-06 Provides for the treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment with Vivitrol.
N021903 NeoProfen ibuprofen lysine Farmacon-IL, LLC 2 P, O 13-Apr-06 Provides for  the treatment for closure of a clinically significant patent ductus arteriosus in premature infants weighing between 500 and 1500 g, who are no more than 32 weeks gestational age when usual medical management (e.g.., fluid restriction, diuretics, respiratory support, etc.) is ineffective.
N021928 Chantix varenicline Pfizer 1 P 10-May-06 Provides for use as an aid for smoking cessation.

N021976

Prezista darunavir Tibotec 1 P 23-Jun-06 When coadministered with 100 mg of ritonavir, provides for the treatment of human immunodeficiency virus (HIV) infection in antiretroviral treatment-experienced adult patients, such as those with HIV-1 strains resistant to more than one protease inhibitor.

N021986

Sprycel dasatinib Bristol-Myers Squibb 1 P, O 28-Jun-06 Provides for the treatment of adults with chronic myeloid leukemia with resistance or intolerance to prior therapy including imatinib.
N021937 Atripla efavirenz; emtricitabine; tenofovir disoproxil fumarate Gilead Sciences 4 P 12-Jul-06 Provides for the treatment of HIV-1 either alone or in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults.
N022003 Noxafil posaconazole Schering 1 P 15-Sep-06 Provides for the treatment of prophylaxis of invasive Aspergillus and Candida infections in patients, 13 years of age and older, who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with Graft versus Host Disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy.
N021983 Duodote atropine; pralidoxime chloride Meridian Medical Technologies 5 P 28-Sep-06 Provides for the treatment of poisoning by organophosphorous nerve agents as well as organophosphorous insecticides.
N021991 Zolinza vorinostat Merck 1 P,O 06-Oct-06 Provides for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL) who have progressive, persistent or recurrent disease on or following two systemic therapies.
N022041 Cyanokit hydroxocobalamin EMD Pharms 3 P,O 15-Dec-06 Provides for the treatment of known or suspected cyanide poisoning.

 

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

NDA Number Proprietary Name Established Name Applicant Chemical Type Review Classification Approval Date Indication
N021943 efavirenz; lamivudine; zidovudine efavirenz; lamivudine;  zidovudine Aurobindo 4 P 06-Mar-06 Provides in combination with other antiretroviral agents for the treatment of HIV-1 infection.
N021939 lamivudine; zidovudine; nevirapine  lamivudine; zidovudine; nevirapine Aurobindo 4 P 30-Jun-06 Provides in combination with other antiretroviral agents for the treatment of HIV-1 infection. 
N021944 lamivudine; zidovudine; abacavir sulfate lamivudine; zidovudine;  abacavir sulfate Aurobindo 4 P 30-Jun-06 Provides in combination with other antiretroviral agents for the treatment of HIV-1 infection.
N022018 lamivudine; zidovudine; lamivudine; zidovudine; Pharmacare 4 P 28-Aug-06 Provides in combination with other antiretroviral agents for the treatment of HIV-1 infection.
N021969 lamivudine; stavudine; nevirapine lamivudine; stavudine; nevirapine Cipla Limited 4 P 17-Nov-06 Provides in combination with other antiretroviral agents for the treatment of HIV-1 infection.

N021943 is lamivudine 150mg/zidovudine 300mg Fixed-Dose Tablets co-packaged with efavirenz 600mg Tablets.

N021939 is lamivudine 150mg/zidovudine 300mg/nevirapine 200mg.

N021944 is lamivudine 150mg/zidovudine 300mg co-packaged with abacavir 300mg Tablets.

N022018 is lamivudine 150mg/zidovudine 300mg.

N021969 lamivudine 150mg/stavudine 30mg/nevirapine 200mg and  lamivudine 150mg/stavudine 40mg/nevirapine 200mg Tablets

 

Priority Biologic License Application (BLA) Approvals:

BLA Number Proprietary Name Proper Name Applicant Review Classification Approval Date Indication

125141

Myozyme alglucosidase alfa Genzyme P, O 28-Apr-06

Provides for the treatment of Pompe disease (GAA deficiency).

125156

Lucentis ranibizumab Genentech P 30-Jun-06 Provides for the treatment of patients with neovascular (wet) age-related macular degenaration.
125151 Elaprase idursulfase Shire Human Genetic Therapies P, O 24-Jul-06 Provides for the treatment of patients with Hunter syndrome (Mucopolysaccharidosis II, MPS II).
125147 Vectibix panitumumab Amgen P 27-Sep-06 Provides for the treatment of EGFR-expressing metastatic colorectal carcinoma with disease progression on or following fluoropyrimidine, oxaliplatin, and irinotecan containing chemotherapy regimens.

 

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).