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2014 FDA drug approvals

已有 3989 次阅读 2015-2-9 18:32 |个人分类:好文转载|系统分类:科研笔记

From

Nature Reviews Drug Discovery 14, 77–81(2015) doi:10.1038/nrd4545



Drug (brand name)SponsorPropertiesIndicationsReview types


Dapagliflozin (Farxiga)AstraZenecaSGLT2 inhibitorType 2 diabetesS
Tasimelteon (Hetlioz)VandaMelatonin-receptor agonistNon-24-hour sleep–wake disorderP, O
Elosulfase alfa (Vimizim)BioMarinHydrolytic lysosomal glycosaminoglycan-specific enzymeMucopolysaccharidosis type IVAP, O
Droxidopa (Northera)LundbeckSynthetic amino-acid precursor of noradrenaline; MOA unknownLight-headedness in patients with neurogenic orthostatic hypotensionP, O, A
Metreleptin (Myalept)AmylinLeptin analogueLeptin deficiency in patients with congenital or acquired generalized lipodystrophyP, O
Florbetaben-F18 (Neuraceq)Piramal ImagingRadioactive diagnostic agentImaging of the brain to estimate density of neuritic amyloid-β plaquesS
Miltefosine (Impavido)KnightMOA unknownLeishmaniasisP, O
Apremilast (Otezla)CelgenePhosphodiesterase 4 inhibitorPsoriatic arthritis and plaque psoriasisS
Albiglutide (Tanzeum)GlaxoSmithKlineGLP1-receptor agonistType 2 diabetesS
Ramucirumab (Cyramza)Eli LillyVEGFR2 antagonistGastric cancerP, O
Siltuximab (Sylvant)Janssen BiotechIL-6-specific antibodyMulticentric Castleman's diseaseP, O
Ceritinib (Zykadia)NovartisKinase inhibitor against ALK, IGF1R, insulin receptor and ROS1ALK-positive metastatic NSCLCP, O, B, A
Vorapaxar (Zontivity)Merck & Co.Protease-activated receptor 1 antagonistThrombotic cardiovascular eventsS
Vedolizumab (Entyvio)TakedaIntegrin-receptor antagonistUlcerative colitis and Crohn's diseaseP
Dalbavancin (Dalvance)DurataSemisynthetic lipoglycopeptideABSSSIP
Efinaconazole (Jublia)DowAzole antifungalOnychomycosis of the toenailsS
Tedizolid (Sivextro)CubistOxazolidinone-class antibacterialABSSSIP
Belinostat (Beleodaq)SpectrumHistone-deacetylase inhibitorPeripheral T-cell lymphomaP, O, A
Tavaborole (Kerydin)AnacorOxaborole antifungalOnychomycosis of the toenailsS
Idelalisib (Zydelig)Gilead SciencesPI3Kб inhibitorCLL, B-cell non-Hodgkin lymphoma and SLLP, O, B, A
Olodaterol (Striverdi Respimat)Boehringer IngelheimLong-acting β2-adrenoceptor agonistCOPDS
Empagliflozin (Jardiance)Boehringer IngelheimSGLT2 inhibitorType 2 diabetesS
Oritavancin (Orbactiv)The Medicines CompanySemi-synthetic lipoglycopeptideABSSSIP
Suvorexant (Belsomra)Merck & Co.Orexin-receptor antagonistInsomniaS
Peginterferon beta-1A (Plegridy)Biogen IdecLong-acting interferon-β1ARelapsing multiple sclerosisS
Eliglustat (Cerdelga)GenzymeGlucosylceramide-synthase inhibitorGaucher's diseaseP, O
Pembrolizumab (Keytruda)Merck & Co.PD1-specific antibodyMetastatic melanomaP, O, B, A
Naloxegol (Movantik)AstraZenecaOpioid-receptor antagonistOpioid-induced constipationS
Dulaglutide (Trulicity)Eli LillyGLP1-receptor agonistType 2 diabetesS
Sulfur hexafluoride lipid-type A microspheres (Lumason)BraccoUltrasound contrast agentCardiovascular imagingS
Netupitant plus palonosetron (Akynzeo)HelsinnAn NK1-receptor antagonist plus a 5-HT3-receptor antagonistChemotherapy-related nauseaS
Ledipasvir plus sofosbuvir (Harvoni)Gilead SciencesAn NS5A inhibitor plus an HCV nucleotide-analogue NS5B-polymerase inhibitorGenotype 1 HCVP, B
Pirfenidone (Esbriet)InterMuneMOA unknownIPFP, O, B
Nintedanib (Ofev)Boehringer IngelheimKinase inhibitor against PDGFRs, FGFRs, VEGFRs and FLT3IPFP, O, B
Blinatumomab (Blincyto)AmgenCD19- and CD3-bispecific antibodyB-ALLP, O, B, A
Finafloxacin (Xtoro)AlconFluoroquinolone antimicrobialAcute otitis externa (swimmer's ear)P
Olaparib (Lynparza)AstraZenecaPARP inhibitorAdvanced BRCA-mutated ovarian cancerP, O, A
Ombitasvir plus paritaprevir plus dasabuvir plus ritonavir (Viekira Pak)AbbVieAn NS5A inhibitor plus an NS3A- and NS4A-protease inhibitor plus a non-nucleoside NS5B-palm-polymerase inhibitor plus a CYP3A inhibitorChronic HCV genotype 1 infectionP, B
Ceftolozane plus tazobactam (Zerbaxa)CubistA cephalosporin antibacterial plus a β-lactamase inhibitorComplicated intra-abdominal infections and complicated urinary tract infectionsP
Peramivir (Rapivab)BioCrystNeuraminidase inhibitorInfluenza infectionS
Nivolumab (Opdivo)Bristol-Myers SquibbPD1 inhibitorUnresectable or metastatic melanomaP, O, B, A

5-HT3, serotonin type 3; A, accelerated approval; ABSSSI, acute bacterial skin and skin structure infection; ALK, anaplastic lymphoma kinase; B, breakthrough designation; B-ALL, B-cell acute lymphocytic leukaemia; CDER, Center for Drug Evaluation and Research; CLL, chronic lymphocytic leukaemia; COPD, chronic obstructive pulmonary disease; CYP3A, cytochrome P450 3A4; FGFR, fibroblast growth factor receptor; FLT3, receptor-type tyrosine-protein kinase FLT3; GLP1, glucagon-like peptide 1; HCV, hepatitis C virus; IGF1R, insulin-like growth factor 1 receptor; IL-6, interleukin-6; IPF, idiopathic pulmonary fibrosis; MOA, mode of action; NK1, substance P; NS, non-structural protein; NSCLC, non-small-cell lung cancer; O, orphan designation; P, priority review; PD1, programmed cell death protein 1; PDGFR, platelet-derived growth factor receptor; PI3Kб, phosphatidylinositol-3-OH kinase; ROS1, proto-oncogene tyrosine-protein kinase ROS; S, standard review; SGLT2, sodium–glucose cotransporter 2; SLL, small lymphocytic lymphoma; VEGFR, vascular endothelial growth factor receptor.


Novel approvals since 1993




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