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
46.Talzennatalazoparib10/16/2018For the treatment of locally advanced or metastatic breast cancer patients with a germline BRCA mutation.
45.Tegsediinotersen10/5/2018To treat polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults
44.Revcovielapegademase-lvlr10/5/2018To treat Adenosine Deaminase-Severe Combined Immunodeficiency (ADA-SCID)
43.Nuzyraomadacycline10/3/2018To treat community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections
42.Seysarasarecycline10/1/2018To treat inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older
41.Libtayocemiplimab-rwlc9/28/2018To treat cutaneous squamous cell carcinoma (CSCC)
Press Release
Drug Trial Snapshot
40.Vizimprodacomitinib9/27/2018To treat metastatic non-small-cell lung cancer
39.Emgalitygalcanezumab-gnlm9/27/2018For the preventive treatment of migraine in adults
38Copiktraduvelisib9/24/2018To treat relapsed or refractory chronic lymphocytic leukemia, small lymphocytic lymphoma and follicular lymphoma
37.Ajovyfremanezumab-vfrm9/14/2018For the preventive treatment of migraine in adults
Drug Trial Snapshot
36.Lumoxitimoxetumomab pasudotox-tdfk9/13/2018To treat hairy cell leukemia
Press Release
Drug Trials Snapshot
35.Pifeltrodoravirine8/30/2018To treat HIV-1 infection in adult patients
Drug Trials Snapshot
34.Xeravaeravacycline8/27/2018To treat complicated intra-abdominal infections in patients 18 years of age and older
33.Takhzyrolanadelumab8/23/2018To treat types I and II hereditary angioedema
More Information
Drug Trials Snapshot
32.Oxervatecenegermin-bkbj8/22/2018To treat neurotrophic keratitis
Press Release
Drug Trials Snapshot
31.Diacomitstiripentol8/20/2018To treat seizures associated with Dravet syndrome in patients 2 years of age and older taking clobazam
Drug Trials Snapshot
30.Galafoldmigalastat8/10/2018To treat treat adults with Fabry disease.
Press Release
Drug Trials Snapshot
29.Annoverasegesterone acetate and ethinyl estradiol vaginal system8/10/2018New vaginal ring used to prevent pregnancy for an entire year
Press Release
Drug Trials Snapshot
28.Onpattropatisiran8/10/2018To treat the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adult patients
Press Release
Drug Trials Snapshot
27.Poteligeomogamulizumab-kpkc8/8/2018To treat two rare types of non-Hodgkin lymphoma
Press Release
Drug Trials Snapshot
26.Mulpletalusutrombopag7/31/2018To treat thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure
Drug Trials Snapshot
25.Omegavenfish oil triglycerides7/27/2018As a source of calories and fatty acids in pediatric patients with parenteral nutrition-associated cholestasis
Drug Trials Snapshot
24.Orilissaelagolix sodium7/23/2018For the management of moderate to severe pain associated with endometriosis
Drug Trials Snapshot
23.Krintafeltafenoquine7/20/2018For the radical cure (prevention of relapse) of Plasmodium vivax malaria
Drug Trials Snapshot
22.Tibsovoivosidenib7/20/2018To treat patients with relapsed or refractory acute myeloid leukemia
Press Release
Drug Trials Snapshot
21.TPOXXtecovirimat7/13/2018To treat smallpox
Press Release
Drug Trials Snapshot
20.Braftoviencorafenib6/27/2018To treat unresectable or metastatic melanoma
FDA Announcement
Drug Trials Snapshot
19.Mektovibinimetinib6/27/2018To treat unresectable or metastatic melanoma
FDA Announcement
Drug Trials Snapshot
18.Zemdriplazomicin6/25/2018To treat adults with complicated urinary tract infections
Drug Trials Snapshot
17.Epidioloexcannabidiol6/25/2018To treat rare, severe forms of epilepsy
Press Release
Drug Trials Snapshot
16.Moxidectinmoxidectin6/13/2018To treat onchocerciasis due to Onchocerca volvulus in patients aged 12 years and older
Drug Trials Snapshot
15.Olumiantbaricitinib5/31/2018To treat moderately to severely active rheumatoid arthritis
Drug Trials Snapshot
14.Palynziqpegvaliase-pqpz5/24/2018To treat adults with a rare and serious genetic disease known as phenylketonuria (PKU)
Press Release
Drug Trials Snapshot
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.

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Page Last Updated: 10/17/2018
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