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NME Drug and New Biologic Approvals in 2006

NME New Drug Application (NDA) Approvals:

NDA Number

Proprietary Name Established Name Applicant Review Classification

Approval Date


N021938 Sutent sunitinib malate Pfizer P 26-Jan-06 Provides for the treatment of gastrointestinal stromal tumor after disease progression on or intolerance to imatinib mesylate. 
N021526 Ranexa ranolazine CV Therapeutics S 27-Jan-06 Provides for the treatment of chronic angina. Because Ranexa prolongs the QT interval, it should be reserved for patients who have not achieved an adequate response with other antianginal drugs.
N021908 Amitiza lubiprostone Sucampo S 31-Jan-06 Provides for the treatment of chronic idiopathic constipation in the adult population.
N021632 Eraxis anidulafungin Vicuron S 17-Feb-06 Provides for the treatment of patients with esophageal candidiasis.
N021790 Dacogen decitabine MGI Pharma S, O 02-May-06 Provides for the treatment of myelodysplastic syndrome (MDS).
N021928 Chantix varenicline Pfizer P 10-May-06 Provides for use as an aid to smoking cessation.
N021641 Azilect rasagiline mesylate Teva S 16-May-06 Provides for the treatment of the signs and symptoms of idiopathic Parkinson's disease as initial monotherapy and as adjunct therapy to levodopa.


Prezista darunavir Tibotec



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 P, O 28-Jun-06 Provides for the treatment of adults with chronic myeloid leukemia with resistance or intolerance to prior therapy including imatinib.
N021502 Anthelios SX avobenzone; ecamsule; octocrylene L'Oreal S 21-Jul-06 Provides for the prevention of sunburn and to help provide protection from UVA and UVB rays.
N022003 Noxafil posaconazole Schering 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.
N050786 Pylera biskalcitrate; metronidazole; tetracycline hydrochloride Axcan Scandipharm S 28-Sep-06 Provides for the treatment of patients with Helicobacter pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori.
N021991 Zolinza vorinostat Merck 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.
N021995 Januvia sitagliptin phosphate Merck S 16-Oct-06 Provides for the use as an adjunct to diet and exercise to improve gylcemic control in patients with type 2 diabetes mellitus as monotherapy and in combination with metformin or a PPARγ agonist (e.g., thiazolidinediones) when diet and excercise plus the single agent do not provide adequate glycemic control.
N022004 Omnaris ciclesonide Altana S 20-Oct-06 Provides for the treatment of seasonal and allergic rhinitis in patients 12 years of age and older.
N022011 Tyzeka telbivudine Idenix S 25-Oct-06 Provides for the treatment of chronic hepatitis B (CHB) in patients with evidence of viral replication and active liver inflammation.
N021902 Veregen kunecatechins MediGene S 31-Oct-06 Provides for the topical treatment of external genital and perianal warts (Condylomata acuminata) in immunocompetent patients 18 years and older.
N021999 Invega paliperidone Janssen, L.P. S 19-Dec-06 Provides for the treatment of schizophrenia.



New Biologic License Application (BLA) Approvals:

BLA Number

Proprietary Name Proper Name Applicant Review Classification

Approval Date


BL125141 Myozyme alglucosidase alfa Genzyme P, O 28-Apr-06

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


Lucentis ranibizumab Genentech



Provides for the treatment of patients with neovascular (wet) age-related macular degeneration.
BL125151 Elaprase idursulfase Shire Human Genetic Therapies P, O 24-Jul-06 Provides for the treatment of patients with Hunter syndrome (Mucopolysaccharidosis II, MPS II).
BL125147 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.

Therapeutic Potentials:  

P -   Priority Review - Significant improvement compared to marketed products, in the treatment, diagnosis, or prevention of a disease.
S -   Standard Review - The drug appears to have therapeutic qualities similar to those of one or more already marketed drugs.
O -   Orphan Designation

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