Drugs

Novel Drug Approvals for 2018

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
15.Olumiantbaricitinib5/31/2018To treat moderately to severely active rheumatoid arthritis
14.Palynziqpegvaliase-pqpz5/24/2018To treat adults with a rare and serious genetic disease known as phenylketonuria (PKU)
Press Release
13.Dopteletavatrombopag5/21/2018To treat low blood platelet count (thrombocytopenia) in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure
Press Release
Drug Trials Snapshot
12.Lokelmasodium zirconium cyclosilicate5/18/2018To treat hyperkalemia
Drug Trials Snapshot
11.Aimovigerenumab-aooe5/17/2018For the preventive treatment for migraine
Press Release
Drug Trials Snapshot
10.Lucemyralofexidine hydrochloride5/16/2018For the non-opioid treatment for management of opioid withdrawal symptoms in adults
Press Release
Drug Trials Snapshot
9.Akynzeofosnetupitant and palonosetron4/19/2018To prevent acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy
Drug Trials Snapshot
8.Crysvitaburosumab-twza4/17/2018To treat adults and children ages 1 year and older with x-linked hypophosphatemia (XLH), a rare, inherited form of rickets
Press Release
Drug Trials Snapshot
7.Tavalissefostamatinib4/17/2018To treat thrombocytopenia in adult patients with persistent or chronic immune thrombocytopenia (ITP)
Drug Trials Snapshot
6.Ilumyatildrakizumab3/20/2018To treat adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy
Drug Trials Snapshot
5.Trogarzoibalizumab-uiyk3/6/2018To treat HIV patients who have limited treatment options
Press Release
Drug Trials Snapshot
4.Erleadaapalutamide2/14/2018To treat a certain type of prostate cancer using novel clinical trial endpoint
Press Release
Drug Trials Snapshot
3.Symdekotezacaftor; ivacaftor2/13/2018To treat cystic fibrosis in patients age 12 years and older
Drug Trials Snapshot
2.Biktarvybictegravir, embitcitabine, tenofovir alafenamide2/7/2018To treat infection in adults who have no antiretroviral treatment history or to replace the current antiretroviral regimen
Drug Trials Snapshot
1.Lutatheralutetium Lu 177 dotatate1/26/2018To treat a type of cancer that affects the pancreas or gastrointestinal tract called gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
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.

Back to Top

Page Last Updated: 06/14/2018
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English