TABLE 1 | New molecular entities and biologics approved by the US FDA in 2006
From the following article:
2006 drug approvals: finding the niche
Joanna Owens
Nature Reviews Drug Discovery 6, 99-101 (February 2007)
doi:10.1038/nrd2247
| Generic name (Trade name) | Company* | Indication | Mode of action | Date |
|---|---|---|---|---|
| New molecular entities | ||||
| Sunitinib malate (Sutent) | Pfizer | Imatinib-resistant gastrointestinal stromal tumour and advanced renal cell carcinoma | Multitargeted kinase inhibitor | 26 Jan |
| Ranolazine (Ranexa) | CV Therapeutics | Chronic angina | Anti-anginal and anti-ischaemic agent | 27 Jan |
| Lubiprostone (Amitiza) | Sucampo | Constipation | Chloride channel inhibitor | 31 Jan |
| Anidulafungin (Eraxis) | Vicuron | Oesophageal candidiasis | Fungal cell-wall synthesis inhibitor | 17 Feb |
| Decitabine (Dacogen) | MGI Pharma | Myelodysplastic syndrome | Demethylating agent | 2 May |
| Varenicline (Chantix) | Pfizer | Smoking cessation | Partial nAch receptor agonist | 10 May |
| Rasagiline mesylate (Azilect) | Teva | Parkinson's disease | Monoamine oxidase B inhibitor | 16 May |
| Darunavir (Prezista) | Tibotec | HIV | Protease inhibitor | 23 Jun |
| Dasatinib (Sprycel) | Bristol–Myers | Chronic myeloid leukaemia | Tyrosine kinase inhibitor | 28 Jun |
| Squibb | ||||
| Avobenzone, ecamsule and octocrylene (Anthelios SX) | L'Oreal | Prevention of sunburn | UVA/UVB filter | 21 Jul |
| Posaconazole (Noxafil) | Schering | Aspergillus and Candida infections | Fungal cell-wall synthesis inhibitor | 15 Sept |
| Biskalcitrate potassium, metronidazole and tetracycline hydrochloride (Pylera) | Axcan | Gastric and duodenal ulcers | Eradication of Helicobacter pylori infection | 28 Sept |
| Scandipharm | ||||
| Vorinostat (Zolinza) | Merck | Cutaneous T-cell lymphoma | Histone deacetylase inhibitor | 6 Oct |
| Sitagliptin phosphate (Januvia) | Merck | Type 2 diabetes | DPP4 inhibitor | 16 Oct |
| Ciclesonide (Omnaris) | Altana | Allergic rhinitis | Corticosteroid | 20 Oct |
| Telbivudine (Tyzeka) | Idenix | Chronic hepatitis B | Reverse transcriptase inhibitor | 25 Oct |
| Kunecatechins (Veregen) | MediGene | External genital and perianal warts | Antioxidant | 31 Oct |
| Paliperidone (Invega) | Janssen | Schizophrenia | Atypical antipsychotic | 19 Dec |
| Biologics | ||||
| Alglucosidase alfa (Myozyme) | Genzyme |  -Glucosidase deficiency (Pompe disease) | Enzyme replacement therapy | 28 Apr |
| Ranibizumab (Lucentis) | Genentech | Neovascular (wet) age-related macular degeneration | Anti-VEGF antibody fragment | 30 Jun |
| Idursulfase (Elaprase) | Shire Human Genetic Therapies | Hunter syndrome (mucopolysaccharidosis II) | Enzyme replacement therapy | 24 Jul |
| Panitumumab (Vectibix) | Amgen | EGFR-expressing metastatic colorectal carcinoma | Anti-EGFR antibody | 27 Sep |
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