Novel Drug Approvals for 2017
Innovation drives progress. When it comes to innovation in the development of new drugs and therapeutic biological products, FDA’s Center for Drug Evaluation and Research (CDER) supports the pharmaceutical industry at every step of the process. With its understanding of the science used to create new products, testing and manufacturing procedures, and the diseases and conditions that new products are designed to treat, CDER provides scientific and regulatory advice needed to bring new therapies to market.
The availability of new drugs and biological products often means new treatment options for patients and advances in health care for the American public. For this reason, CDER supports innovation and plays a key role in helping to advance new drug development.
Each year, CDER approves a wide range of new drugs and biological products:
- Some of these products are innovative new products that never have been used in clinical practice.Below is a listing of new molecular entities and new therapeutic biological products approved by CDER in 2017. This listing does not contain vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products, or other products approved in 2017 by the Center for Biologics Evaluation and Research.
- Others are the same as, or related to, previously approved products, and they will compete with those products in the marketplace.
Certain drugs are classified as new molecular entities (“NMEs”) for purposes of FDA review. Many of these products contain active moieties that have not been approved by FDA previously, either as a single ingredient drug or as part of a combination product; these products frequently provide important new therapies for patients. Some drugs are characterized as NMEs for administrative purposes, but nonetheless contain active moieties that are closely related to active moieties in products that have previously been approved by FDA. For example, CDER classifies biological products submitted in an application under section 351(a) of the Public Health Service Act as NMEs for purposes of FDA review, regardless of whether the Agency previously has approved a related active moiety in a different product. FDA’s classification of a drug as an “NME” for review purposes is distinct from FDA’s determination of whether a drug product is a “new chemical entity” or “NCE” within the meaning of the Federal Food, Drug, and Cosmetic Act.
No. | Drug Name |
Active Ingredient | Approval Date | FDA-approved use on approval date* |
---|---|---|---|---|
46. | Giapreza | angiotensin II | 12/21/2017 | To increase blood pressure in adults with septic or other distributive shock Press Release Drug Trials Snapshot |
45. | Macrilen | macimorelin acetate | 12/20/2017 | For the diagnosis of adult growth hormone deficiency Drug Trials Snapshot |
44. | Steglatro | ertugliflozin | 12/19/2017 | To improve glycemic control in adults with type 2 diabetes mellitus Drug Trials Snapshot |
43. | Rhopressa | netarsudil | 12/18/2017 | To treat glaucoma or ocular hypertension Drug Trials Snapshot |
42. | Xepi | ozenoxacin | 12/11/2017 | To treat impetigo Drug Trials Snapshot |
41. | Ozempic | semaglutide | 12/5/2017 | To improve glycemic control in adults with type 2 diabetes mellitus Drug Trials Snapshot |
40. | Hemlibra | emicizumab | 11/16/2017 | To prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A who have developed antibodies called Factor VIII (FVIII) inhibitors. Press Release Drug Trials Snapshot |
39. | Mepsevii | vestronidase alfa-vjbk | 11/15/2017 | To treat pediatric and adult patients with an inherited metabolic condition called mucopolysaccharidosis type VII (MPS VII), also known as Sly syndrome. Press Release Drug Trials Snapshot |
38. | Fasenra | benralizumab | 11/14/2017 | For add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype Drug Trials Snapshot |
37. | Prevymis | letermovir | 11/8/2017 | To prevent infection after bone marrow transplant Drug Trials Snapshot |
36. | Vyzulta | latanoprostene bunod ophthalmic solution | 11/2/2017 | To treat intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Drug Trials Snapshot |
35. | Calquence | acalabrutinib | 10/31/2017 | To treat adults with mantle cell lymphoma Press Release Drug Trials Snapshot |
34. | abemaciclib | 9/28/2017 | To treat certain advanced or metastatic breast cancers Press Release Drug Trials Snapshot |
|
33. | secnidazole | 9/15/2017 | To treat bacterial vaginosis Drug Trials Snapshot |
|
32. | copanlisib | 9/14/2017 | To treat adults with relapsed follicular lymphoma Press Release Drug Trials Snapshot |
|
31. | benznidazole | benznidazole | 8/29/2017 | To treat children ages 2 to 12 years old with Chagas disease Press Release Drug Trials Snapshot |
30. | meropenem and vaborbactam | 8/29/2017 | To treat adults with complicated urinary tract infections Press Release Drug Trials Snapshot |
|
29. | inotuzumab ozogamicin | 8/17/2017 | To treat adults with relapsed or refractory acute lymphoblastic leukemia Press Release Drug Trials Snapshot |
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28. | Mavyret | glecaprevir and pibrentasvir | 8/3/2017 | To treat adults with chronic hepatitis C virus Press Release Drug Trials Snapshot |
27. | Idhifa | enasidenib | 8/1/2017 | To treat relapsed or refractory acute myeloid leukemia Press Release Drug Trials Snapshot |
26. | Vosevi | sofosbuvir, velpatasvir and voxilaprevir | 7/18/2017 | To treat adults with chronic hepatitis C virus Press Release Drug Trials Snapshot |
25. | Nerlynx | neratinib maleate | 7/17/2017 | To reduce the risk of breast cancer returning Press Release Drug Trials Snapshot |
24. | Tremfya | guselkumab | 7/13/2017 | For the treatment of adult patients with moderate-to-severe plaque psoriasis Drug Trials Snapshot |
23. | Bevyxxa | betrixaban | 6/23/2017 | For the prophylaxis of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness Drug Trials Snapshot |
22. | Baxdela | delafloxacin | 6/19/2017 | To treat patients with acute bacterial skin infections Drug Trials Snapshot |
21. | Kevzara | sarilumab | 5/22/2017 | To treat adult rheumatoid arthritis Drug Trials Snapshot |
20. | Radicava | edaravone | 5/5/2017 | To treat patients with amyotrophic lateral sclerosis (ALS) Press Release Drug Trials Snapshot |
19. | Imfinzi | durvalumab | 5/1/2017 | To treat patients with locally advanced or metastatic urothelial carcinoma Web Post Drug Trials Snapshot |
18. | Tymlos | abaloparatide | 4/28/2017 | To treat osteoporosis in postmenopausal women at high risk of fracture or those who have failed other therapies Drug Trials Snapshot |
17. | Rydapt | midostaurin | 4/28/2017 | To treat acute myeloid leukemia, advanced systemic mastocytosis Press Release Drug Trials Snapshot for advanced systemic mastocytosis Drug Trials Snapshot for acute Myeloid leukemia |
16. | Alunbrig | brigatinib | 4/28/2017 | To treat patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib Drug Trials Snapshot |
15. | Brineura | cerliponase alfa | 4/27/2017 | To treat a specific form of Batten disease Press Release Drug Trials Snapshot |
14. | Ingrezza | valbenazine | 4/11/2017 | To treat adults with tardive dyskinesia Press Release Drug Trials Snapshot |
13. | Austedo | deutetrabenazine | 4/3/2017 | For the treatment of chorea associated with Huntington’s disease Drug Trials Snapshot |
12. | Ocrevus | ocrelizumab | 3/28/2017 | To treat patients with relapsing and primary progressive forms of multiple sclerosis Press Release Drug Trials Snapshot |
11. | Dupixent | dupilumab | 3/28/2017 | To treat adults with moderate-to-severe eczema (atopic dermatitis) Press Release Drug Trials Snapshot |
10. | Zejula | niraparib | 3/27/2017 | For the maintenance treatment for recurrent epithelial ovarian, fallopian tube or primary peritoneal cancers Press Release Drug Trials Snapshot |
9. | Symproic |
naldemedine |
3/23/2017 |
For the treatment of opioid-induced constipation |
8. | Bavencio | avelumab | 3/23/2017 | To treat metastatic Merkel cell carcinoma Press Release Drug Trials Snapshot |
7. | Xadago | safinamide | 3/21/2017 | To treat Parkinson’s disease Press Release Drug Trials Snapshot |
6. | Kisqali | ribociclib | 3/13/2017 | To treat postmenopausal women with a type of advanced breast cancer Drug Trials Snapshot |
5. | Xermelo | telotristat ethyl | 2/28/2017 | To treat carcinoid syndrome diarrhea Press Release Drug Trials Snapshot |
4. | Siliq | brodalumab | 2/15/2017 | To treat adults with moderate-to-severe plaque psoriasis Press Release Drug Trials Snapshot |
3. | Emflaza | deflazacort | 2/9/2017 | To treat patients age 5 years and older with Duchenne muscular dystrophy (DMD) Press Release Drug Trials Snapshot |
2. | Parsabiv | etelcalcetide | 2/7/2017 | To treat secondary hyperparathyroidism in adult patients with chronic kidney disease undergoing dialysis Drug Trials Snapshot |
1. | Trulance | plecanatide | 1/19/2017 | To treat Chronic Idiopathic Constipation (CIC) in adult patients. Press Release Drug Trials Snapshot |
*The listed “FDA-approved use” on this website is for presentation purposes only. To see the FDA-approved conditions of use [e.g., indication(s), population(s), dosing regimen(s)] for each of these products, see the most recent FDA-approved Prescribing Information (click on the Drug Name).