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Novel Drug Approvals for 2018


No.Drug
NameActive IngredientApproval DateFDA-approved use on approval date*59.Ultomirisravulizumab12/21/2018To treat paroxysmal nocturnal hemoglobinuria (PNH)
Press Release
Drug Trials Snapshot58.Elzonristagraxofusp-erzs12/21/2018To treat blastic plasmacytoid dendritic cell neoplasm (BPDCN)
Press Release
Drug Trials Snapshot57.Asparlascalaspargase pegol-mknl12/20/2018To treat acute lymphoblastic leukemia (ALL) in pediatric and young adult patients age 1 month to 21 years
Drug Trials Snapshot56.Motegrityprucalopride12/14/2018To treat chronic idiopathic constipation
Drug Trials Snapshot55.Xospatagilteritinib11/28/2018To treat patients who have relapsed or refractory acute myeloid leukemia (AML)
Press Release
Drug Trials Snapshot54.Firdapseamifampridine11/28/2028To treat  Lambert-Eaton myasthenic syndrome (LEMS) in adults
Press Release
Drug Trials Snapshot53.Vitrakvilarotrectinib11/26/2018To treat patients whose cancers have a specific genetic feature (biomarker)
Press Release
Drug Trials Snapshot52.Daurismoglasdegib11/21/2018To treat newly-diagnosed acute myeloid leukemia (AML) in adult patients
Press Release 
Drug Trials Snapshot51.Gamifantemapalumab-lzsgemapalumab-lzsg11/20/2018To treat primary hemophagocytic lymphohistiocytosis (HLH)
Press Release
Drug Trials Snapshot50.Aemcolorifamycin11/16/2018To treat travelers’ diarrhea
Press Release
Drug Trials Snapshot49.Yupelrirevefenacin11/9/2018To treat patients with chronic obstructive pulmonary disease (COPD)
Drug Trials Snapshot48.Lorbrenalorlatinib11/2/2018To treat patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer
Drug Trials Snapshot47.Xofluzabaloxavir marboxil10/24/2018To treat acute uncomplicated influenza in patients who have been symptomatic for no more than 48 hours.
Press Release
Drug Trials Snapshot46.Talzennatalazoparib10/16/2018To treat locally advanced or metastatic breast cancer patients with a germline BRCA mutation.
Drug Trials Snapshot45.Tegsediinotersen10/5/2018To treat polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults
Drug Trials Snapshot44.Revcovielapegademase-lvlr10/5/2018To treat Adenosine Deaminase-Severe Combined Immunodeficiency (ADA-SCID)
Drug Trials Snapshot43.Nuzyraomadacycline10/2/2018To treat community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections
Drug Trials Snapshot for community-acquired bacterial pneumonia42.Seysarasarecycline10/1/2018To treat inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older
Drug Trials Snapshot41.Libtayocemiplimab-rwlc9/28/2018To treat cutaneous squamous cell carcinoma (CSCC)
Drug Trial Snapshot40.Vizimprodacomitinib9/27/2018To treat metastatic non-small-cell lung cancer
Drug Trials Snapshot39.Emgalitygalcanezumab-gnlm9/27/2018For the preventive treatment of migraine in adults
Drug Trials Snapshot38.Copiktraduvelisib9/24/2018To treat relapsed or refractory chronic lymphocytic leukemia, small lymphocytic lymphoma and follicular lymphoma
Drug Trials Snapshot37.Ajovyfremanezumab-vfrm9/14/2018For the preventive treatment of migraine in adults
Drug Trials Snapshot36.Lumoxitimoxetumomab pasudotox-tdfk9/13/2018To treat hairy cell leukemia
Press Release
Drug Trials Snapshot35.Pifeltrodoravirine8/30/2018To treat HIV-1 infection in adult patients
Drug Trials Snapshot34.Xeravaeravacycline8/27/2018To treat complicated intra-abdominal infections in patients 18 years of age and older
Drug Trials Snapshot33.Takhzyrolanadelumab8/23/2018To treat types I and II hereditary angioedema
Drug Trials Snapshot32.Oxervatecenegermin-bkbj8/22/2018To treat neurotrophic keratitis
Press Release
Drug Trials Snapshot31.Diacomitstiripentol8/20/2018To treat seizures associated with Dravet syndrome in patients 2 years of age and older taking clobazam
Drug Trials Snapshot30.Galafoldmigalastat8/10/2018To treat treat adults with Fabry disease.
Press Release
Drug Trials Snapshot29.Annoverasegesterone acetate and ethinyl estradiol vaginal system8/10/2018New vaginal ring used to prevent pregnancy for an entire year
Press Release
Drug Trials Snapshot28.Onpattropatisiran8/10/2018To treat the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adult patients
Press Release
Drug Trials Snapshot27.Poteligeomogamulizumab-kpkc8/8/2018To treat two rare types of non-Hodgkin lymphoma
Press Release
Drug Trials Snapshot26.Mulpletalusutrombopag7/31/2018To treat thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure
Drug Trials Snapshot25.Omegavenfish oil triglycerides7/27/2018As a source of calories and fatty acids in pediatric patients with parenteral nutrition-associated cholestasis
Drug Trials Snapshot24.Orilissaelagolix sodium7/23/2018For the management of moderate to severe pain associated with endometriosis
Drug Trials Snapshot23.Krintafeltafenoquine7/20/2018For the radical cure (prevention of relapse) of Plasmodium vivax malaria
Drug Trials Snapshot22.Tibsovoivosidenib7/20/2018To treat patients with relapsed or refractory acute myeloid leukemia
Press Release
Drug Trials Snapshot21.TPOXXtecovirimat7/13/2018To treat smallpox
Press Release
Drug Trials Snapshot20.Braftoviencorafenib6/27/2018To treat unresectable or metastatic melanoma
Drug Trials Snapshot19.Mektovibinimetinib6/27/2018To treat unresectable or metastatic melanoma
Drug Trials Snapshot18.Zemdriplazomicin6/25/2018To treat adults with complicated urinary tract infections
Drug Trials Snapshot17.Epidioloexcannabidiol6/25/2018To treat rare, severe forms of epilepsy
Press Release
Drug Trials Snapshot16.Moxidectinmoxidectin6/13/2018To treat onchocerciasis due to Onchocerca volvulus in patients aged 12 years and older
Drug Trials Snapshot15.Olumiantbaricitinib5/31/2018To treat moderately to severely active rheumatoid arthritis
Drug Trials Snapshot14.Palynziqpegvaliase-pqpz5/24/2018To treat adults with a rare and serious genetic disease known as phenylketonuria (PKU)
Press Release
Drug Trials Snapshot13.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 Snapshot12.Lokelmasodium zirconium cyclosilicate5/18/2018To treat hyperkalemia
Drug Trials Snapshot11.Aimovigerenumab-aooe5/17/2018For the preventive treatment for migraine
Press Release
Drug Trials Snapshot10.Lucemyralofexidine hydrochloride5/16/2018For the non-opioid treatment for management of opioid withdrawal symptoms in adults
Press Release
Drug Trials Snapshot9.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 Snapshot8.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 Snapshot7.Tavalissefostamatinib4/17/2018To treat thrombocytopenia in adult patients with persistent or chronic immune thrombocytopenia (ITP)
Drug Trials Snapshot6.Ilumyatildrakizumab3/20/2018To treat adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy
Drug Trials Snapshot5.Trogarzoibalizumab-uiyk3/6/2018To treat HIV patients who have limited treatment options
Press Release
Drug Trials Snapshot4.Erleadaapalutamide2/14/2018To treat a certain type of prostate cancer using novel clinical trial endpoint
Press Release
Drug Trials Snapshot3.Symdekotezacaftor; ivacaftor2/12/2018To treat cystic fibrosis in patients age 12 years and older
Drug Trials Snapshot2.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 Snapshot1.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



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