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U.S. Department of Health and Human Services

Drugs

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NME Drug and New Biologic Approvals in 2007

NME New Drug Application (NDA) Approvals:

NDA Number Proprietary Name Established Name Applicant Review Classification Approval Date Indication
N021977 Vyvanse lisdexamfetamine dimesylate New River S 23-Feb-07 Provides for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD).
N021985 Tekturna aliskiren Novartis S 05-Mar-07 Provides for the treatment of hypertension.
N022059 Tykerb lapatinib GlaxoSmithKline 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..
N022055 Altabax retapamulin GlaxoSmithKline S 12-Apr-07 Provides for the treatment of impetigo.
N021829 Neupro rotigotine Schwarz BioSciences S 09-May-07 Provides for the treatment of the signs and symptoms of early-stage idiopathic Parkinson’s disease.
N022088 Torisel temsirolimus Wyeth P,O 30-May-07 Provides for the treatment of advanced renal cell carcinoma.
N022081 Letairis ambrisentan Gilead Sciences P,O 15-Jun-07 Provides for the treatment of pulmonary arterial hypertension (WHO Group I) in patients with WHO class II or III symptoms to improve exercise capacity and delay clinical worsening.
N022128 Selzentry maraviroc Pfizer P 06-Aug-07 Provides for the treatment of patients infected with CCR5-tropic HIV-1.
N022119 Ammonia N13 ammonia Feinstein S 23-Aug-07 Provides for the treatment as a radioactive diagnostic agent for Positron Emission Tomography (PET), for diagnostic PET imaging of the myocardium under rest or pharmacologic stress conditions to evaluate myocardial perfusion in patients with suspected or existing coronary artery disease.
N022074 Somatuline Depot lanreotide Biomeasure S,O 30-Aug-07 Provides for the long-term treatment of acromegalic patients who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy.
N022106 Doribax doripenem Johnson & Johnson S 12-Oct-2007 Provides for the treatment of complicated intra-abdominal (cIAI) and complicated urinary tract (eUTI) infections caused by susceptible isolates of the designated microorganisms.
N022145 Isentress raltegravir potassium Merck 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 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.
N022068 Tasigna nilotinib Novartis S,O 29-Oct-2007 Provides for the treatment of chronic phase (CP) and accelerated phase (AP) Philadelphia chromosome positive chronic myelogenous leukemia (CML) in adult patients resistant to or intolerant to prior therapy that included Gleevec (imatinib).
N022181 Kuvan sapropterin dihydrochloride BioMarin 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).
N021742 Bystolic nebivolol Mylan Bertek S 17-Dec-2007 Provides for the treatment of hypertension alone or in combination with other antihypertensive agents.

 

New 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-07 Provides for the treatment of paroxysmal nocturnal hemoglobinuria to reduce hemolysis.
BL125164 Mircera methoxy polyethylene glycol-epoetin beta Hoffman
La-Roche
S 14-Nov-07 Provides for the treatment of anemia associated with chronic renal failure, including patients on dialysis and patients not on dialysis.


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