FDA novel drug approvals 2017
Views & Analysis
| No. | Drug Name | Active Ingredient | Company | FDA-approved use on approval date |
|---|---|---|---|---|
| 46. | Giapreza | angiotensin II | La Jolla | To increase blood pressure in adults with septic or other distributive shock |
| 45. | Macrilen | macimorelin acetate | Aeterna Zentaris | For the diagnosis of adult growth hormone deficiency |
| 44. | Steglatro | ertugliflozin | Merck & Co. and Pfizer | To improve glycaemic control in adults with type 2 diabetes |
| 43. | Rhopressa | netarsudil | Aerie Pharmaceuticals | Glaucoma or ocular hypertension |
| 42. | Xepi | ozenoxacin | Medimetriks Pharmaceuticals | Impetigo |
| 41. | Ozempic | semaglutide | Novo Nordisk | Type 2 diabetes |
| 40. | Hemlibra | emicizumab | Roche | Adult and paediatric patients with haemophilia A who have Factor VIII inhibitors. |
| 39. | Mepsevii | vestronidase alfa-vjbk | Ultragenyx | Mucopolysaccharidosis type VII (MPS VII), also known as Sly syndrome. |
| 38. | Fasenra | benralizumab | AstraZeneca (MedImmune) | Add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype |
| 37. | Prevymis | letermovir | Merck & Co. | To prevent infection after bone marrow transplant |
| 36. | Vyzulta | latanoprostene bunod ophthalmic solution | Valeant and Nicox | Intraocular pressure in patients with open-angle glaucoma or ocular hypertension. |
| 35. | Calquence | acalabrutinib | AstraZeneca | Mantle cell lymphoma |
| 34. | Verzenio | abemaciclib | Eli Lilly | Advanced or metastatic breast cancers |
| 33. | Solosec | secnidazole | Symbiomix Therapeutics | Bacterial vaginosis |
| 32. | Aliqopa | copanlisib | Bayer | Relapsed follicular lymphoma |
| 31. | benznidazole | benznidazole | Insud Pharma | Children ages 2 to 12 years old with Chagas disease |
| 30. | Vabomere | meropenem and vaborbactam | Medicines Company | Complicated urinary tract infections |
| 29. | Besponsa | inotuzumab ozogamicin | Pfizer | Relapsed or refractory acute lymphoblastic leukaemia |
| 28. | Mavyret | glecaprevir and pibrentasvir | AbbVie | Chronic hepatitis C virus |
| 27. | Idhifa | enasidenib | Celgene | Relapsed or refractory acute myeloid leukaemia |
| 26. | Vosevi | sofosbuvir, velpatasvir and voxilaprevir | Gilead | Adults with chronic hepatitis C virus |
| 25. | Nerlynx | neratinib maleate | Puma Biotechnology | To reduce the risk of breast cancer returning |
| 24. | Tremfva | guselkumab | Janssen | Moderate-to-severe plaque psoriasis |
| 23. | Bevyxxa | betrixaban | Portola Pharmaceuticals | Prophylaxis of venous thromboembolism (VTE) in adult patients hospitalised for an acute medical illness |
| 22. | Baxdela | delafloxacin | Melinta Therapeutics | Acute bacterial skin infections |
| 21. | Kevzara | sarilumab | Sanofi and Regeneron | Rheumatoid arthritis |
| 20. | Radicava | edaravone | Mitsubishi Tanabe | Amyotrophic lateral sclerosis (ALS) |
| 19. | Imfinzi | durvalumab | AstraZeneca | Locally advanced or metastatic urothelial carcinoma |
| 18. | Tymlos | abaloparatide | Radius Health | Osteoporosis in postmenopausal women at high risk of fracture or those who have failed other therapies |
| 17. | Rydapt | midostaurin | Novartis | Acute myeloid leukaemia |
| 16. | Alumbrig | brigatinib | Takeda | ALK+ metastatic NSCLC patients who have progressed on or are intolerant to crizotinib |
| 15. | Brineura | cerliponase alfa | BioMarin | Batten disease |
| 14. | Ingrezza | valbenazine | Neurocrine Biosciences | Tardive dyskinesia |
| 13. | Austedo | deutetrabenazine | Teva | Chorea associated with Huntington’s disease |
| 12. | Ocrevus | ocrelizumab | Roche | Relapsing and primary progressive forms of multiple sclerosis |
| 11. | Dupixent | dupilumab | Regeneron and Sanofi | Adults with moderate-to-severe eczema (atopic dermatitis) |
| 10. | Zejula | niraparib | Tesaro | Maintenance treatment for recurrent epithelial ovarian, fallopian tube or primary peritoneal cancers |
| 9. | Symproic | naldemedine | Purdue Pharma and Shionogi | Opioid-induced constipation |
| 8. | Bavencio | avelumab | EMD Serono and Pfizer | Metastatic Merkel cell carcinoma |
| 7. | Xadago | safinamide | Newron Pharmaceuticals. | Parkinson’s disease |
| 6. | Kisqali | ribociclib | Novartis | advanced HR+/HER2- breast cancer in postmenopausal women |
| 5. | Xermelo | telotristat ethyl | Lexicon | Carcinoid syndrome diarrhoea |
| 4. | Siliq | brodalumab | Valeant | Adults with moderate-to-severe plaque psoriasis |
| 3. | Emflaza | deflazacort | PTC Therapeutics | Duchenne muscular dystrophy (DMD) |
| 2. | Parsabiv | etelcalcetide | Amgen | Secondary hyperparathyroidism in patients with chronic kidney disease undergoing dialysis |
| 1. | Trulance | plecanatide | Synergy Pharmaceuticals | Chronic Idiopathic Constipation (CIC) in adult patients. |
