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27 Jan 2019

Key Insights on 2018 USFDA new drug approval

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USFDA new drug appproval year by year

YearNumber of New Molecule Approved by USFDA
201859 >> Highest number of new drug approval from 2011.
201746
201622
201545
201441
201327
201239
201129

List of New Drugs approved in 2018 by USFDA

No.Drug Name Active IngredientFDA-approved use on approval date
59UltomirisravulizumabTo treat paroxysmal nocturnal hemoglobinuria (PNH)
58Elzonristagraxofusp-erzsTo treat blastic plasmacytoid dendritic cell neoplasm (BPDCN)
57Asparlascalaspargase pegol-mknlTo treat acute lymphoblastic leukemia (ALL) in pediatric and young adult patients age 1 month to 21 years
56MotegrityprucaloprideTo treat chronic idiopathic constipation
55XospatagilteritinibTo treat patients who have relapsed or refractory acute myeloid leukemia (AML)
54FirdapseamifampridineTo treat  Lambert-Eaton myasthenic syndrome (LEMS) in adults
53VitrakvilarotrectinibTo treat patients whose cancers have a specific genetic feature (biomarker)
52DaurismoglasdegibTo treat newly-diagnosed acute myeloid leukemia (AML) in adult patients
51Gamifantemapalumab-lzsgTo treat primary hemophagocytic lymphohistiocytosis (HLH) 
49YupelrirevefenacinTo treat patients with chronic obstructive pulmonary disease (COPD)
48LorbrenalorlatinibTo treat patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer
47Xofluzabaloxavir marboxilFor the treatment of acute uncomplicated influenza in patients who have been symptomatic for no more than 48 hours. 
46TalzennatalazoparibFor the treatment of locally advanced or metastatic breast cancer patients with a germline BRCA mutation. 
45TegsediinotersenTo treat polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults
44Revcovielapegademase-lvlrTo treat Adenosine Deaminase-Severe Combined Immunodeficiency (ADA-SCID)
43NuzyraomadacyclineTo treat community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections
42SeysarasarecyclineTo treat inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older
41Libtayocemiplimab-rwlcTo treat cutaneous squamous cell carcinoma (CSCC) 
40VizimprodacomitinibTo treat metastatic non-small-cell lung cancer
39Emgalitygalcanezumab-gnlmFor the preventive treatment of migraine in adults
38CopiktraduvelisibTo treat relapsed or refractory chronic lymphocytic leukemia, small lymphocytic lymphoma and follicular lymphoma
37Ajovyfremanezumab-vfrmFor the preventive treatment of migraine in adults
36Lumoxitimoxetumomab pasudotox-tdfkTo treat hairy cell leukemia
35PifeltrodoravirineTo treat HIV-1 infection in adult patients
34XeravaeravacyclineTo treat complicated intra-abdominal infections in patients 18 years of age and older
33TakhzyrolanadelumabTo treat types I and II hereditary angioedema
32Oxervatecenegermin-bkbjTo treat neurotrophic keratitis
31DiacomitstiripentolTo treat seizures associated with Dravet syndrome in patients 2 years of age and older taking clobazam
30GalafoldmigalastatTo treat treat adults with Fabry disease. 
29Annoverasegesterone acetate and ethinyl estradiol vaginal systemNew vaginal ring used to prevent pregnancy for an entire year 
28OnpattropatisiranTo treat the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adult patients
27Poteligeomogamulizumab-kpkcTo treat two rare types of non-Hodgkin lymphoma
26MulpletalusutrombopagTo treat thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure
25Omegavenfish oil triglyceridesAs a source of calories and fatty acids in pediatric patients with parenteral nutrition-associated cholestasis
24Orilissaelagolix sodiumFor the management of moderate to severe pain associated with endometriosis
23KrintafeltafenoquineFor the radical cure (prevention of relapse) of Plasmodium vivax malaria
22TibsovoivosidenibTo treat patients with relapsed or refractory acute myeloid leukemia 
21TPOXXtecovirimatTo treat smallpox
20BraftoviencorafenibTo treat unresectable or metastatic melanoma 
19MektovibinimetinibTo treat unresectable or metastatic melanoma 
18ZemdriplazomicinTo treat adults with complicated urinary tract infections
17EpidiolexcannabidiolTo treat rare, severe forms of epilepsy
16MoxidectinmoxidectinTo treat onchocerciasis due to Onchocerca volvulus in patients aged 12 years and older
15OlumiantbaricitinibTo treat moderately to severely active rheumatoid arthritis
14Palynziqpegvaliase-pqpzTo treat adults with a rare and serious genetic disease known as phenylketonuria (PKU)
13DopteletavatrombopagTo treat low blood platelet count (thrombocytopenia) in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure
12Lokelmasodium zirconium cyclosilicateTo treat hyperkalemia
11Aimovigerenumab-aooeFor the preventive treatment for migraine
10Lucemyralofexidine hydrochlorideFor the non-opioid treatment for management of opioid withdrawal symptoms in adults
9Akynzeofosnetupitant and palonosetronTo prevent acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy
8Crysvitaburosumab-twzaTo treat adults and children ages 1 year and older with x-linked hypophosphatemia (XLH), a rare, inherited form of rickets
7TavalissefostamatinibTo treat thrombocytopenia in adult patients with persistent or chronic immune thrombocytopenia (ITP)
6IlumyatildrakizumabTo treat adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy
5Trogarzoibalizumab-uiykTo treat HIV patients who have limited treatment options
4ErleadaapalutamideTo treat a certain type of prostate cancer using novel clinical trial endpoint
3Symdekotezacaftor; ivacaftorTo treat cystic fibrosis in patients age 12 years and older
2Biktarvybictegravir, embitcitabine, tenofovir alafenamideTo treat infection in adults who have no antiretroviral treatment history or to replace the current antiretroviral regimen
1Lutatheralutetium Lu 177 dotatateTo treat a type of cancer that affects the pancreas or gastrointestinal tract called gastroenteropancreatic neuroendocrine tumors (GEP-NETs).

New Drug Approval in different Specialty

Therapeutic Category Number of Drug Approved
Dermatology 7
Family Medicine 3
Gastroenterology 4
Genetic Disease 6
Hematology 17
Immunology 8
Infections and Infectious Diseases14
Internal Medicine 1
Musculoskeletal3
Nephrology 1
Neurology 9
Obstetrics/Gynecology (Women’s Health)5
Oncology 17
Ophthalmology1
Pediatrics/Neonatology6
Pharmacology/Toxicology2
Pulmonary/Respiratory Diseases6
Rheumatology1
Urology 3

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