Priority NDA and BLA Approvals in 2006


Priority New Drug Application (NDA) Approvals:

NDA NumberProprietary NameEstablished NameApplicantChemical TypeReview ClassificationApproval DateIndication
N021938Sutentsunitinib malatePfizer1P26-Jan-06Provides 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. .
N021980FluorescitefluoresceinAlcon Research5P28-Mar-06Provides for the use in diagnostic fluoresceine angiography or angioscopy of the retina and iris vasculature.
N021897VivitrolnaltrexoneAlkermes3P13-Apr-06Provides 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.
N021903NeoProfenibuprofen lysineFarmacon-IL, LLC2P, O13-Apr-06Provides 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.
N021928ChantixvareniclinePfizer1P10-May-06Provides for use as an aid for smoking cessation.


PrezistadarunavirTibotec1P23-Jun-06When 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.


SpryceldasatinibBristol-Myers Squibb1P, O28-Jun-06Provides for the treatment of adults with chronic myeloid leukemia with resistance or intolerance to prior therapy including imatinib.
N021937Atriplaefavirenz; emtricitabine; tenofovir disoproxil fumarateGilead Sciences4P12-Jul-06Provides for the treatment of HIV-1 either alone or in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults.
N022003NoxafilposaconazoleSchering1P15-Sep-06Provides 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.
N021983Duodoteatropine; pralidoxime chlorideMeridian Medical Technologies5P28-Sep-06Provides for the treatment of poisoning by organophosphorous nerve agents as well as organophosphorous insecticides.
N021991ZolinzavorinostatMerck1P,O06-Oct-06Provides 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.
N022041CyanokithydroxocobalaminEMD Pharms3P,O15-Dec-06Provides 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 NumberProprietary NameEstablished NameApplicantChemical TypeReview ClassificationApproval DateIndication
N021943efavirenz; lamivudine; zidovudineefavirenz; lamivudine;  zidovudineAurobindo4P06-Mar-06Provides in combination with other antiretroviral agents for the treatment of HIV-1 infection.
N021939lamivudine; zidovudine; nevirapine lamivudine; zidovudine; nevirapineAurobindo4P30-Jun-06Provides in combination with other antiretroviral agents for the treatment of HIV-1 infection. 
N021944lamivudine; zidovudine; abacavir sulfatelamivudine; zidovudine;  abacavir sulfateAurobindo4P30-Jun-06Provides in combination with other antiretroviral agents for the treatment of HIV-1 infection.
N022018lamivudine; zidovudine;lamivudine; zidovudine;Pharmacare4P28-Aug-06Provides in combination with other antiretroviral agents for the treatment of HIV-1 infection.
N021969lamivudine; stavudine; nevirapinelamivudine; stavudine; nevirapineCipla Limited4P17-Nov-06Provides 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 NumberProprietary NameProper NameApplicantReview ClassificationApproval DateIndication


Myozymealglucosidase alfaGenzymeP, O28-Apr-06

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


LucentisranibizumabGenentechP30-Jun-06Provides for the treatment of patients with neovascular (wet) age-related macular degenaration.
125151ElapraseidursulfaseShire Human Genetic TherapiesP, O24-Jul-06Provides for the treatment of patients with Hunter syndrome (Mucopolysaccharidosis II, MPS II).
125147VectibixpanitumumabAmgenP27-Sep-06Provides 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:
-   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).


Page Last Updated: 11/03/2015
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