Drugs

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, FDA 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 before have been used in clinical practice. 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 IngredientApproval DateFDA-approved use on approval date
23.BEVYXXAbetrixaban6/23/2017For the prophylaxis of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness
22.Baxdeladelafloxacin6/19/2017To treat patients with acute bacterial skin infections
21.Kevzarasarilumab5/22/2017To treat adult rheumatoid arthritis
Drug Trials Snapshot
20.Radicavaedaravone5/5/2017To treat patients with amyotrophic lateral sclerosis (ALS)
Press Release
Drug Trials Snapshot
19.Imfinzidurvalumab5/1/2017To treat patients with locally advanced or metastatic urothelial carcinoma
Web Post
Drug Trials Snapshot
18.Tymlosabaloparatide4/28/2017To treat osteoporosis in postmenopausal women at high risk of fracture or those who have failed other therapies
Drug Trials Snapshot
17.Rydaptmidostaurin4/28/2017To treat acute myeloid leukemia
Press Release
Drug Trials Snapshot
16.Alunbrigbrigatinib4/28/2017To 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.Brineuracerliponase alfa4/27/2017To treat a specific form of Batten disease
Press Release
Drug Trials Snapshot
14.Ingrezzavalbenazine4/11/2017To treat adults with tardive dyskinesia 
Press Release  
Drug Trials Snapshot
13.Austedodeutetrabenazine 4/3/2017 For the treatment of chorea associated with Huntington’s disease 
Drug Trials Snapshot
12.Ocrevusocrelizumab3/28/2017To treat patients with relapsing and primary progressive forms of multiple sclerosis
Press Release
Drug Trials Snapshot
11.Dupixentdupilumab3/28/2017To treat adults with moderate-to-severe eczema (atopic dermatitis)
Press Release
Drug Trials Snapshot
10.Zejulaniraparib3/27/2017For 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
Drug Trials Snapshot

8.Bavencioavelumab3/23/2017To treat metastatic Merkel cell carcinoma
Press Release
Drug Trials Snapshot
7.Xadagosafinamide3/21/2017To treat Parkinson’s disease
Press Release
Drug Trials Snapshot
6.Kisqaliribociclib3/13/2017To treat postmenopausal women with a type of advanced breast cancer
Drug Trials Snapshot
5.Xermelotelotristat ethyl2/28/2017To treat carcinoid syndrome diarrhea
Press Release
Drug Trials Snapshot
4.Siliqbrodalumab2/15/2017To treat adults with moderate-to-severe plaque psoriasis
Press Release
Drug Trials Snapshot
3.Emflazadeflazacort2/9/2017To treat patients age 5 years and older with Duchenne muscular dystrophy (DMD)
Press Release
Drug Trials Snapshot
2.Parsabivetelcalcetide2/8/2017To treat secondary hyperparathyroidism in adult patients with chronic kidney disease undergoing dialysis
Drug Trials Snapshot
1.Trulanceplecanatide1/19/2017To treat Chronic Idiopathic Constipation (CIC) in adult patients.
Press Release
Drug Trials Snapshot

* This information is currently accurate. In rare instances, it may be necessary for FDA to change a drug’s new molecular entity (NME) designation or the status of its application as a novel new biologics license application (BLA).  For instance, new information may become available which could lead to a reconsideration of the original designation or status.  If changes must be made to a drug’s designation or the status of an application as a novel BLA, the Agency intends to communicate the nature of, and the reason for, any revisions as appropriate.
 

Page Last Updated: 06/23/2017
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