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
 55.Xospatagilteritinib11/28/2018To treat patients who have relapsed or refractory acute myeloid leukemia (AML)
Press Release
 54.Firdapseamifampridine11/28/2018To treat  Lambert-Eaton myasthenic syndrome (LEMS) in adults
Press Release
 53.Vitrakvilarotrectinib11/26/2018To treat patients whose cancers have a specific genetic feature (biomarker)
Press Release
 52.Daurismoglasdegib11/21/2018To treat newly-diagnosed acute myeloid leukemia (AML) in adult patients
Press Release 
 51.Gamifantemapalumab-lzsg11/20/2018To treat primary hemophagocytic lymphohistiocytosis (HLH)
Press Release
Drug Trials Snapshot
 50.Aemcolorifamycin11/16/2018To treat travelers’ diarrhea
Press Release
Drug Trials Snapshot
 49.Yupelrirevefenacin11/8/2018To treat patients with chronic obstructive pulmonary disease (COPD)
Drug Trials Snapshot
 48.Lorbrenalorlatinib11/2/2018To treat patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer
Drug Trials Snapshot
 47.Xofluzabaloxavir marboxil10/24/2018For the treatment of acute uncomplicated influenza in patients who have been symptomatic for no more than 48 hours.
Press Release
Drug Trials Snapshot
 46.Talzennatalazoparib10/16/2018

For the treatment of locally advanced or metastatic breast cancer patients with a germline BRCA mutation.
Drug Trials Snapshot 

 45.Tegsediinotersen10/5/2018To treat polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults
Drug Trials Snapshot
 44.Revcovielapegademase-lvlr10/5/2018To treat Adenosine Deaminase-Severe Combined Immunodeficiency (ADA-SCID)
Drug Trials Snapshot
 43.Nuzyraomadacycline10/3/2018To treat community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections
Drug Trials Snapshot
 42.Seysarasarecycline10/1/2018To treat inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older
Drug Trials Snapshot
 41.Libtayocemiplimab-rwlc9/28/2018To treat cutaneous squamous cell carcinoma (CSCC)
Press Release
Drug Trials Snapshot
 40.Vizimprodacomitinib9/27/2018To treat metastatic non-small-cell lung cancer
Drug Trials Snapshot
 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
Drug Trials Snapshot
 37.Ajovyfremanezumab-vfrm9/14/2018For the preventive treatment of migraine in adults
Drug Trials 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.Epidiolexcannabidiol6/25/2018To 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: 12/07/2018
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