Table 1 FDA approvals in the first 6 months of 2014
Drug (brand name) | Lead company | Indication |
|---|---|---|
Dapagliflozin (Farxiga) | AstraZeneca | Type 2 diabetes |
Tasimelteon (Hetlioz) | Vanda | Non-24-hour sleep–wake disorder |
Elosulfase alfa (Vimizim)* | Biomarin | Mucopolysaccharidosis type IVA |
Droxidopa (Northera) | Chelsea Therapeutics | Neurogenic orthostatic hypotension |
Metreleptin (Myalept)* | Amylin | Leptin deficiency in patients with congenital or acquired generalized lipodystrophy |
Florbetaben F-18 (Neuraceq) | Piramal | Imaging of the brain to estimate β-amyloid neuritic plaque density |
Miltefosine (Impavido) | Paladin | Leishmania donovani, Leishmania braziliensis, Leishmania guyanensis or Leishmania panamensis infection |
Apremilast (Otezla) | Celgene | Psoriatic arthritis |
Albiglutide (Tanzeum)* | GlaxoSmithKline | Type 2 diabetes |
Ramucirumab (Cyramza)* | Eli Lilly | Gastric cancer |
Siltuximab (Sylvant)* | Janssen | Multicentric Castleman's disease |
Ceritinib (Zykadia) | Novartis | Anaplastic lymphoma kinase (ALK)-positive metastatic non-small-cell lung cancer |
Vorapaxar (Zontivity) | Merck & Co. | Thrombotic cardiovascular events in patients with a history of myocardial infarction or peripheral arterial disease |
Vedolizumab (Entyvio)* | Takeda | Ulcerative colitis and Crohn's disease |
Dalbavancin (Dalvance) | Durata | ABSSSI caused by designated susceptible Gram-positive microorganisms |
Efinaconazole (Jublia) | Dow Pharmaceuticals | Onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophyte |
Tedizolid (Sivextro) | Cubist | ABSSSI caused by designated susceptible Gram-positive microorganisms |
