TABLE 1 | New molecular entities and biologics approved by the US FDA in 2007
From the following article:
2007 FDA drug approvals: a year of flux
Bethan Hughes
Nature Reviews Drug Discovery 7, 107-109 (February 2008)
doi:10.1038/nrd2514
| Generic name (Trade name) | Company* | Indication‡ | Mode of action | Date |
|---|---|---|---|---|
| New molecular entities | ||||
| Lisdexamfetamine dimesylate (Vyvanse) | New River | Attention–deficit/hyperactivity disorder http://www.fda.gov/cder/foi/label/2007/021977s002lbl.pdf | Prodrug of dextroamphetamine with CNS stimulant activity | 23 Feb (S) |
| Aliskiren (Tekturna) | Novartis | Hypertension http://www.fda.gov/cder/foi/label/2007/021985lbl.pdf | Direct renin inhibitor | 5 Mar (S) |
| Lapatinib (Tykerb) | GlaxoSmithKline | Advanced or metastatic breast cancer http://www.fda.gov/cder/foi/label/2007/022059s002lbl.pdf | Kinase inhibitor with targets including HER2 (also known as ERBB2) | 13 Mar (P) |
| Retapamulin (Altabax) | GlaxoSmithKline | Impetigo http://www.fda.gov/cder/foi/label/2007/022055lbl.pdf | Bacterial protein-synthesis inhibitor | 12 Apr (S) |
| Rotigotine (Neupro) | Schwarz BioSciences | Early stage idiopathic Parkinson's disease http://www.fda.gov/cder/foi/label/2007/021829lbl.pdf | Dopamine receptor agonist | 9 May (S) |
| Temsirolimus (Torisel) | Wyeth | Advanced renal cell carcinoma http://www.fda.gov/cder/foi/label/2007/022088lbl.pdf | Mammalian target of rapamycin (mTOR) inhibitor | 30 May (P, O) |
| Ambrisentan (Letairis) | Gilead Sciences | Pulmonary arterial hypertension http://www.fda.gov/cder/foi/label/2007/022081s000_lbl.pdf | Endothelin receptor antagonist | 15 Jun (P, O) |
| Maraviroc (Selzentry) | Pfizer | CCR5-tropic HIV-1 http://www.fda.gov/cder/foi/label/2007/022128lbl.pdf | CCR5 co-receptor antagonist | 6 Aug (P) |
| Ammonia (Ammonia N13) | Feinstein | Radioactive agent for positron emission tomography diagnosis of coronary artery disease§ | – | 23 Aug (S) |
| Lanreotide (Somatuline Depot) | Biomeasure | Acromegaly http://www.fda.gov/cder/foi/label/2007/022074lbl.pdf | Somatostatin analogue | 30 Aug (S, O) |
| Doripenem (Doribax) | Johnson & Johnson | Urinary tract infections http://www.fda.gov/cder/foi/label/2007/022106lbl.pdf | Synthetic broad-spectrum carbapenem antibiotic | 12 Oct (S) |
| Raltegravir potassium (Isentress) | Merck | HIV-1 http://www.fda.gov/cder/foi/label/2007/022145lbl.pdf | HIV integrase strand transfer inhibitor | 12 Oct (P) |
| Ixabepilone (Ixempra) | Bristol–Myers Squibb | Advanced or metastatic breast cancer http://www.fda.gov/cder/foi/label/2007/022065lbl.pdf | Microtubule inhibitor | 16 Oct (P) |
| Nilotinib (Tasigna) | Novartis | Chronic myelogenous leukaemia http://www.fda.gov/cder/foi/label/2007/022068lbl.pdf | BCR–ABL kinase inhibitor | 29 Oct (S, O) |
| Sapropterin dihydrochloride (Kuvan) | BioMarin | Hyperphenylalaninaemia http://www.fda.gov/cder/foi/label/2007/022181lbl.pdf | Synthetic tetrahydrobiopterin, cofactor for the enzyme phenylalanine hydroxylase | 13 Dec (P, O) |
| Nebivolol (Bystolic) | Mylan Bertek | Hypertension§ |  -adrenoceptor antagonist | 17 Dec (S) |
| Hydroxyethyl starch (Voluven) | Fresenius Kabi | Serious blood volume loss§ | Blood volume expander | 27 Dec |
| Biologics | ||||
| Eculizumab (Soliris) | Alexion | Paroxysmal nocturnal haemogobinuria http://www.fda.gov/cder/foi/label/2007/125166lbl.pdf | Recombinant humanized monoclonal immunoglobulin G2/4 antibody that binds to complement protein C5 | 16 Mar (P, O) |
| Methoxy polyethylene glycol-epoetin beta (Mircera) | Hoffman La-Roche | Anaemia associated with chronic renal failure http://www.fda.gov/cder/foi/label/2007/125164lbl.pdf | Erythropoietin receptor activator | 14 Nov (P) |
| *The company that submitted the original new drug application or biologic license application to the US FDA.‡See full labelling information online.§Label not available at time of going to press.Information not available at time of going to press. O, FDA Orphan designation; P, FDA Priority Review; S, FDA Standard Review. | ||||
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