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
|S||14-Nov-07||Provides for the treatment of anemia associated with chronic renal failure, including patients on dialysis and patients not on dialysis.|
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).