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2014 FDA drug approvals
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From
Nature Reviews Drug Discovery 14, 77–81(2015) doi:10.1038/nrd4545
| Drug (brand name) | Sponsor | Properties | Indications | Review types |
|---|---|---|---|---|
| Dapagliflozin (Farxiga) | AstraZeneca | SGLT2 inhibitor | Type 2 diabetes | S |
| Tasimelteon (Hetlioz) | Vanda | Melatonin-receptor agonist | Non-24-hour sleep–wake disorder | P, O |
| Elosulfase alfa (Vimizim) | BioMarin | Hydrolytic lysosomal glycosaminoglycan-specific enzyme | Mucopolysaccharidosis type IVA | P, O |
| Droxidopa (Northera) | Lundbeck | Synthetic amino-acid precursor of noradrenaline; MOA unknown | Light-headedness in patients with neurogenic orthostatic hypotension | P, O, A |
| Metreleptin (Myalept) | Amylin | Leptin analogue | Leptin deficiency in patients with congenital or acquired generalized lipodystrophy | P, O |
| Florbetaben-F18 (Neuraceq) | Piramal Imaging | Radioactive diagnostic agent | Imaging of the brain to estimate density of neuritic amyloid-β plaques | S |
| Miltefosine (Impavido) | Knight | MOA unknown | Leishmaniasis | P, O |
| Apremilast (Otezla) | Celgene | Phosphodiesterase 4 inhibitor | Psoriatic arthritis and plaque psoriasis | S |
| Albiglutide (Tanzeum) | GlaxoSmithKline | GLP1-receptor agonist | Type 2 diabetes | S |
| Ramucirumab (Cyramza) | Eli Lilly | VEGFR2 antagonist | Gastric cancer | P, O |
| Siltuximab (Sylvant) | Janssen Biotech | IL-6-specific antibody | Multicentric Castleman's disease | P, O |
| Ceritinib (Zykadia) | Novartis | Kinase inhibitor against ALK, IGF1R, insulin receptor and ROS1 | ALK-positive metastatic NSCLC | P, O, B, A |
| Vorapaxar (Zontivity) | Merck & Co. | Protease-activated receptor 1 antagonist | Thrombotic cardiovascular events | S |
| Vedolizumab (Entyvio) | Takeda | Integrin-receptor antagonist | Ulcerative colitis and Crohn's disease | P |
| Dalbavancin (Dalvance) | Durata | Semisynthetic lipoglycopeptide | ABSSSI | P |
| Efinaconazole (Jublia) | Dow | Azole antifungal | Onychomycosis of the toenails | S |
| Tedizolid (Sivextro) | Cubist | Oxazolidinone-class antibacterial | ABSSSI | P |
| Belinostat (Beleodaq) | Spectrum | Histone-deacetylase inhibitor | Peripheral T-cell lymphoma | P, O, A |
| Tavaborole (Kerydin) | Anacor | Oxaborole antifungal | Onychomycosis of the toenails | S |
| Idelalisib (Zydelig) | Gilead Sciences | PI3Kб inhibitor | CLL, B-cell non-Hodgkin lymphoma and SLL | P, O, B, A |
| Olodaterol (Striverdi Respimat) | Boehringer Ingelheim | Long-acting β2-adrenoceptor agonist | COPD | S |
| Empagliflozin (Jardiance) | Boehringer Ingelheim | SGLT2 inhibitor | Type 2 diabetes | S |
| Oritavancin (Orbactiv) | The Medicines Company | Semi-synthetic lipoglycopeptide | ABSSSI | P |
| Suvorexant (Belsomra) | Merck & Co. | Orexin-receptor antagonist | Insomnia | S |
| Peginterferon beta-1A (Plegridy) | Biogen Idec | Long-acting interferon-β1A | Relapsing multiple sclerosis | S |
| Eliglustat (Cerdelga) | Genzyme | Glucosylceramide-synthase inhibitor | Gaucher's disease | P, O |
| Pembrolizumab (Keytruda) | Merck & Co. | PD1-specific antibody | Metastatic melanoma | P, O, B, A |
| Naloxegol (Movantik) | AstraZeneca | Opioid-receptor antagonist | Opioid-induced constipation | S |
| Dulaglutide (Trulicity) | Eli Lilly | GLP1-receptor agonist | Type 2 diabetes | S |
| Sulfur hexafluoride lipid-type A microspheres (Lumason) | Bracco | Ultrasound contrast agent | Cardiovascular imaging | S |
| Netupitant plus palonosetron (Akynzeo) | Helsinn | An NK1-receptor antagonist plus a 5-HT3-receptor antagonist | Chemotherapy-related nausea | S |
| Ledipasvir plus sofosbuvir (Harvoni) | Gilead Sciences | An NS5A inhibitor plus an HCV nucleotide-analogue NS5B-polymerase inhibitor | Genotype 1 HCV | P, B |
| Pirfenidone (Esbriet) | InterMune | MOA unknown | IPF | P, O, B |
| Nintedanib (Ofev) | Boehringer Ingelheim | Kinase inhibitor against PDGFRs, FGFRs, VEGFRs and FLT3 | IPF | P, O, B |
| Blinatumomab (Blincyto) | Amgen | CD19- and CD3-bispecific antibody | B-ALL | P, O, B, A |
| Finafloxacin (Xtoro) | Alcon | Fluoroquinolone antimicrobial | Acute otitis externa (swimmer's ear) | P |
| Olaparib (Lynparza) | AstraZeneca | PARP inhibitor | Advanced BRCA-mutated ovarian cancer | P, O, A |
| Ombitasvir plus paritaprevir plus dasabuvir plus ritonavir (Viekira Pak) | AbbVie | An NS5A inhibitor plus an NS3A- and NS4A-protease inhibitor plus a non-nucleoside NS5B-palm-polymerase inhibitor plus a CYP3A inhibitor | Chronic HCV genotype 1 infection | P, B |
| Ceftolozane plus tazobactam (Zerbaxa) | Cubist | A cephalosporin antibacterial plus a β-lactamase inhibitor | Complicated intra-abdominal infections and complicated urinary tract infections | P |
| Peramivir (Rapivab) | BioCryst | Neuraminidase inhibitor | Influenza infection | S |
| Nivolumab (Opdivo) | Bristol-Myers Squibb | PD1 inhibitor | Unresectable or metastatic melanoma | P, 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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