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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

USFDA new molecule approved in 2018

No.	Drug Name	Active Ingredient	FDA-approved use on approval date
59	Ultomiris	ravulizumab	To treat paroxysmal nocturnal hemoglobinuria (PNH)
58	Elzonris	tagraxofusp-erzs	To treat blastic plasmacytoid dendritic cell neoplasm (BPDCN)
57	Asparlas	calaspargase pegol-mknl	To treat acute lymphoblastic leukemia (ALL) in pediatric and young adult patients age 1 month to 21 years
56	Motegrity	prucalopride	To treat chronic idiopathic constipation
55	Xospata	gilteritinib	To treat patients who have relapsed or refractory acute myeloid leukemia (AML)
54	Firdapse	amifampridine	To treat Lambert-Eaton myasthenic syndrome (LEMS) in adults
53	Vitrakvi	larotrectinib	To treat patients whose cancers have a specific genetic feature (biomarker)
52	Daurismo	glasdegib	To treat newly-diagnosed acute myeloid leukemia (AML) in adult patients
51	Gamifant	emapalumab-lzsg	To treat primary hemophagocytic lymphohistiocytosis (HLH)
49	Yupelri	revefenacin	To treat patients with chronic obstructive pulmonary disease (COPD)
48	Lorbrena	lorlatinib	To treat patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer
47	Xofluza	baloxavir marboxil	For the treatment of acute uncomplicated influenza in patients who have been symptomatic for no more than 48 hours.
46	Talzenna	talazoparib	For the treatment of locally advanced or metastatic breast cancer patients with a germline BRCA mutation.
45	Tegsedi	inotersen	To treat polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults
44	Revcovi	elapegademase-lvlr	To treat Adenosine Deaminase-Severe Combined Immunodeficiency (ADA-SCID)
43	Nuzyra	omadacycline	To treat community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections
42	Seysara	sarecycline	To treat inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older
41	Libtayo	cemiplimab-rwlc	To treat cutaneous squamous cell carcinoma (CSCC)
40	Vizimpro	dacomitinib	To treat metastatic non-small-cell lung cancer
39	Emgality	galcanezumab-gnlm	For the preventive treatment of migraine in adults
38	Copiktra	duvelisib	To treat relapsed or refractory chronic lymphocytic leukemia, small lymphocytic lymphoma and follicular lymphoma
37	Ajovy	fremanezumab-vfrm	For the preventive treatment of migraine in adults
36	Lumoxiti	moxetumomab pasudotox-tdfk	To treat hairy cell leukemia
35	Pifeltro	doravirine	To treat HIV-1 infection in adult patients
34	Xerava	eravacycline	To treat complicated intra-abdominal infections in patients 18 years of age and older
33	Takhzyro	lanadelumab	To treat types I and II hereditary angioedema
32	Oxervate	cenegermin-bkbj	To treat neurotrophic keratitis
31	Diacomit	stiripentol	To treat seizures associated with Dravet syndrome in patients 2 years of age and older taking clobazam
30	Galafold	migalastat	To treat treat adults with Fabry disease.
29	Annovera	segesterone acetate and ethinyl estradiol vaginal system	New vaginal ring used to prevent pregnancy for an entire year
28	Onpattro	patisiran	To treat the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adult patients
27	Poteligeo	mogamulizumab-kpkc	To treat two rare types of non-Hodgkin lymphoma
26	Mulpleta	lusutrombopag	To treat thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure
25	Omegaven	fish oil triglycerides	As a source of calories and fatty acids in pediatric patients with parenteral nutrition-associated cholestasis
24	Orilissa	elagolix sodium	For the management of moderate to severe pain associated with endometriosis
23	Krintafel	tafenoquine	For the radical cure (prevention of relapse) of Plasmodium vivax malaria
22	Tibsovo	ivosidenib	To treat patients with relapsed or refractory acute myeloid leukemia
21	TPOXX	tecovirimat	To treat smallpox
20	Braftovi	encorafenib	To treat unresectable or metastatic melanoma
19	Mektovi	binimetinib	To treat unresectable or metastatic melanoma
18	Zemdri	plazomicin	To treat adults with complicated urinary tract infections
17	Epidiolex	cannabidiol	To treat rare, severe forms of epilepsy
16	Moxidectin	moxidectin	To treat onchocerciasis due to Onchocerca volvulus in patients aged 12 years and older
15	Olumiant	baricitinib	To treat moderately to severely active rheumatoid arthritis
14	Palynziq	pegvaliase-pqpz	To treat adults with a rare and serious genetic disease known as phenylketonuria (PKU)
13	Doptelet	avatrombopag	To treat low blood platelet count (thrombocytopenia) in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure
12	Lokelma	sodium zirconium cyclosilicate	To treat hyperkalemia
11	Aimovig	erenumab-aooe	For the preventive treatment for migraine
10	Lucemyra	lofexidine hydrochloride	For the non-opioid treatment for management of opioid withdrawal symptoms in adults
9	Akynzeo	fosnetupitant and palonosetron	To prevent acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy
8	Crysvita	burosumab-twza	To treat adults and children ages 1 year and older with x-linked hypophosphatemia (XLH), a rare, inherited form of rickets
7	Tavalisse	fostamatinib	To treat thrombocytopenia in adult patients with persistent or chronic immune thrombocytopenia (ITP)
6	Ilumya	tildrakizumab	To treat adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy
5	Trogarzo	ibalizumab-uiyk	To treat HIV patients who have limited treatment options
4	Erleada	apalutamide	To treat a certain type of prostate cancer using novel clinical trial endpoint
3	Symdeko	tezacaftor; ivacaftor	To treat cystic fibrosis in patients age 12 years and older
2	Biktarvy	bictegravir, embitcitabine, tenofovir alafenamide	To treat infection in adults who have no antiretroviral treatment history or to replace the current antiretroviral regimen
1	Lutathera	lutetium Lu 177 dotatate	To treat a type of cancer that affects the pancreas or gastrointestinal tract called gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
No.	Drug Name	Active Ingredient	FDA-approved use on approval date

USFDA New Drug Approval in different Specialty in 2018

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