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The novel drugs marketed in 2018

January 03, 2019 By 1℃

The attached table shows the novel drugs marketed in 2018.

The novel drugs marketed in 2018

The novel drugs marketed in 2018

Order No.

Trade name

Common name

Approval date

Mechanism

Indication

Company

56

Motegrity

prucalopride

2018-12-14

5-HT4 receptor agonist

Chronic idiopathic constipation

J & J/Shire

55

Xospata

gilteritinib

2018-11-28

Axl/Flt3 inhibitor

r/r-AML

Astellas Pharma

54

Firdapse

amifampridine

2018-11-28

Potassium channel blocker

Lambert-Eaton myasthenic syndrome

Catalyst Pharmaceuticals

53

Vitrakvi

larotrectinib

2018-11-26

TRK inhibitor

Advanced solid tumors harboring an NTRK gene fusion

Loxo Oncology

52

Daurismo

glasdegib

2018-11-21

SMO receptor agonist

Acute leukemia

Pfizer

51

Gamifant

emapalumab

2018-11-20

INFγ mAb

Primary hemophagocytic lymphohistiocytosis

Novimmune sobi

50

Aemcolo

rifamycin

2018-11-16

Rifamycin

Travelers’ diarrhea

Cosmo Pharmaceuticals

49

Yupelri

revefenacin

2018-11-8

mAChR inhibitor

Chronic obstructive pulmonary disease

Theravance Biopharma; Mylan

48

Lorbrena

lorlatinib

2018-11-2

ALK inhibitor

ALK-positive NSCLC

Pfizer

47

Xofluza

baloxavir marboxil

2018-10-24

Small molecule inhibitor of cap-dependent endonuclease

Influenza

Roche

46

Talzenna

talazoparib

2018-10-16

PARP inhibitor

Locally advanced or metastatic breast cancer

Pfizer

45

Tegsedi

inotersen

2018-10-5

TTR antisense therapy

Polyneuropathy of hereditary transthyretin-mediated amyloidosis

Ionis pharmaceuticals; GSK

44

Revcovi

elapegademase-lvlr

2018-10-5

Recombinant adenosine deaminase

Adenosine Deaminase-Severe Combined Immunodeficiency

Leadiant Biosciences

43

Nuzyra

omadacycline

2018-10-3

Tetracycline antibiotic

ABSSSI; CABP

Paratek Pharmaceuticals

42

Seysara

sarecycline

2018-10-1

Tetracycline antibiotic

Acne vulgaris

Allergan

41

Libtayo

cemiplimab-rwlc

2018-9-28

Anti-PD-1 mAb

Metastatic/locally advanced CSCC

Regeneron

40

Vizimpro

dacomitinib

2018-9-27

EGFR tyrosine kinase inhibitor

NSCLC

Pfizer

39

Emgality

galcanezumab-gnlm

2018-9-27

CGRP mAb

Migraine

Eli Lilly;Arteaus Therapeutics

38

Copiktra

duvelisib

2018-9-24

PI3K inhibitor

r/r-CLL, r/r-SLL, r/r-follicular lymphoma

Verastem Oncology

37

Ajovy

fremanezumab-vfrm

2018-9-14

CGRP mAb

Cluster headache

Teva

36

Lumoxiti

moxetumomab pasudotox-tdfk

2018-9-13

Anti-siglec-2 immunotoxin drug

Hairy cell leukemia

AstraZeneca

35

Pifeltro

doravirine

2018-8-30

Reverse transcriptase (RT)

HIV

MSD

34

Xerava

eravacycline

2018-8-27

Tetracycline

Complicated urinary tract infection

Everest Medicines;

33

Takhzyro

lanadelumab

2018-8-23

KLK mAb

Hereditary angioedema

Shire

32

Oxervate

cenegermin-bkbj

2018-8-22

Recombinant nerve growth factor

Neurotrophic keratitis

Dompé Farmaceutici

31

Diacomit

stiripentol

2018-8-20

NA

Dravet syndrome

BIOCODEX SAS

30

Galafold

migalastat

2018-8-10

α-galactosidase promoter

Fabry disease

Amicus Therapeutics

29

Annovera

segesterone acetate and ethinyl estradiol vaginal system

2018-8-10

Segesterone+ethinyloestradiol

Pregnancy prevention

The Population Council

28

Onpattro

patisiran

2018-8-10

TTR RNAi

Polyneuropathy of hereditary transthyretin-mediated amyloidosis

Alnylam; Sanofi

27

Poteligeo

mogamulizumab-kpkc

2018-8-8

CCR4 mAb

Rare, hard-to-treat types of non-Hodgkin lymphoma

Kyowa Hakko Kirin Co., Ltd.

26

Mulpleta

lusutrombopag

2018-7-31

TPO receptor agonist

Thrombocytopenia caused by chronic liver disease

Shionogi

25

Omegaven

fish oil triglycerides

2018-7-27

Intravenous emulsion with triglycerides

Cholestasis

Fresenius Kabi

24

Orilissa

elagolix sodium

2018-7-23

Gonadotropin-releasing hormone (GnRH) receptor antagonist

Endometriosis

AbbVie

23

Krintafel

tafenoquine

2018-7-20

Aminoquinoline drug

Plasmodium vivax malaria

GSK

22

Tibsovo

ivosidenib

2018-7-20

IDH1 inhibitor

Relapsed or refractory acute myeloid leukemia

Agios Pharmaceuticals

21

TPOXX

tecovirimat

2018-7-13

P37 protein inhibitor

Smallpox

SIGA Technologies

20

Braftovi

encorafenib

2018-6-27

 BRAF inhibitor

BRAFV600E/V600K+ metastatic melanoma

Array BioPharma

19

Mektovi

binimetinib

2018-6-27

 BRAF inhibitor

BRAFV600E/V600K+ metastatic melanoma

Array BioPharma

18

Zemdri

plazomicin

2018-6-25

Aminoglycoside antibiotic

Urinary tract infections

Achaogen

17

Epidiolex

cannabidiol

2018-6-25

NA

Lennox-Gastaut syndrome and Dravet syndrome

GW Pharmaceuticals

16

Moxidectin

moxidectin

2018-6-13

Macrolide antibiotic

Onchocerciasis

Medicines Development for Global Health

15

Olumiant

baricitinib

2018-5-31

JAK1/2 inhibitor

Moderately to severely active rheumatoid arthritis

Eli Lilly

14

Palynziq

pegvaliase-pqpz

2018-5-24

Recombinant phenylalanine ammonia lyase

Phenylketonuria

BioMarin

13

Doptelet

avatrombopag

2018-5-21

TPO receptor agonist

Low blood platelet count caused by chronic liver disease

Dova Pharmaceuticals

12

Lokelma

sodium zirconium cyclosilicate

2018-5-18

NA

Hyperkalemia

AstraZeneca

11

Aimovig

erenumab-aooe

2018-5-17

CGRP mAb

Migraine

Amgen/Novartis

10

Lucemyra

lofexidine hydrochloride

2018-5-16

α-2 adrenergic receptor agonist

Treatment for management of opioid withdrawal symptoms

US Worldmeds

9

Akynzeo

fosnetupitant and palonosetron

2018-4-19

5-HT3 receptor agonist+NK1 receptor agonist

Acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy

Helsinn Healthcare

8

Crysvita

burosumab-twza

2018-4-17

Anti-FGF23 mAb

Adults and children with x-linked hypophosphatemia (XLH)

Ultragenyx

7

Tavalisse

fostamatinib

2018-4-17

Syk inhibitor

Chronic immune thrombocytopenia

Rigel pharms

6

Ilumya

tildrakizumab

2018-3-20

Anti-IL-23 mAb

Moderate-to-severe plaque psoriasis

Sun Pharmaceutical

5

Trogarzo

ibalizumab-uiyk

2018-03-6

Anti-CD4 mAb

Drug resistant HIV

TaiMed Biologics

4

Erleada

apalutamide

2018-2-14

Androgen receptor inhibitor

Non-metastatic, castration-resistant prostate cancer

J & J

3

Symdeko

tezacaftor; ivacaftor

2018-2-13

CFTR (compound)

Cystic fibrosis

Vertex pharmaceticals

2

Biktarvy

bictegravir, embitcitabine, tenofovir alafenamide

2018-2-7

TAF-component integrase inhibitor drugs

HIV

Gilead

1

Lutathera

lutetium Lu 177 dotatate

2018-1-26

Lu-177-labeled somatostatin analogues

Gastroenteropancreatic neuroendocrine tumors

Advanced Accelerator Applications

Data: FDA

Read More:

Overview of FDA Drug Review in 2018: The Number of Novel Drugs Marketed Hit a 20-year High

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