2018年美国批准FDA上市新药

更新时间:2023-06-30 16:03:18 阅读：评论：0

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 Rearch (CDER) supports the pharmaceutical industry at every step of the process. With its understanding of the science ud to create new products, testing and manufacturing procedures, and the dias 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 the products are innovative new products that never before have been ud in clinical practice. Others are the same as, or related to, previously approved products, and they will compete with tho products in the marketplace.

Certain drugs are classified as new molecular entities (“NMEs”) for purpos of FDA review. Many of the 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; the products frequently provide important new therapies for patients. Some drugs are characterized as NMEs for administrative purpos, but nonetheless contain active moieties that are cloly related to active moieties in products that have previously been approved by FDA. For example, CDER classifies biological products submitted in an application under ction 351(a) of the Public Health Service Act as NMEs for purpos 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 purpos 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.

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序号	药品名	活性物质	批准日期	FDA批准用途
59	Ultomiris	ravulizumab	12/21/2018	To treat paroxysmal nocturnal hemoglobinuria (PNH)
58	Elzonris	tagraxofusp-erzs	12/21/2018	To treat blastic plasmacytoid dendritic cell neoplasm (BPDCN)
57	Asparlas	calasparga pegol-mknl	12/20/2018	To treat acute lymphoblastic leukemia (ALL) in pediatric and young adult patients age 1 month to 21 years
56	Motegrity	prucalopride	12/14/2018	To treat chronic idiopathic constipation
55	Xospata	gilteritinib	11/28/2018	To treat patients who have relapd or refractory acute myeloid leukemia (AML)
54	Firdap	amifampridine	11/28/2018	To treat Lambert-Eaton myasthenic syndrome (LEMS) in adults
53	Vitrakvi	larotrectinib	11/26/2018	To treat patients who cancers have a specific genetic feature (biomarker)
52	Daurismo	glasdegib	11/21/2018	To treat newly-diagnod acute myeloid leukemia (AML) in adult patients
51	Gamifant	emapalumab-lzsg	11/20/2018	To treat primary hemophagocytic lymphohistiocytosis (HLH)
50	Aemcolo	rifamycin	11/16/2018	To treat travelers’ diarrhea
49	Yupelri	revefenacin	11/8/2018	To treat patients with chronic obstructive pulmonary dia (COPD)
48	Lorbrena	lorlatinib	11/2/2018	To treat patients with anaplastic lymphoma kina (ALK)-positive metastatic non-small cell lung cancer
47	Xofluza	baloxavir marboxil	10/24/2018	For the treatment of acute uncomplicated influenza in patients who have been symptomatic for no more than 48 hours.
46	Talzenna	talazoparib	10/16/2018	For the treatment of locally advanced or metastatic breast cancer patients with a germline BRCA mutation.
45	Tegdi	inotern	10/5/2018	To treat polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults
44	Revcovi	elapegadema-lvlr	10/5/2018	To treat Adenosine Deamina-Severe Combined Immunodeficiency (ADA-SCID)
43	Nuzyra	omadacycline	10/3/2018	To treat community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections
42	Seysara	sarecycline	10/1/2018	To treat inflammatory lesions of non-nodular moderate to vere acne vulgaris in patients 9 years of age and older
41	Libtayo	cemiplimab-rwlc	9/28/2018	To treat cutaneous squamous cell carcinoma (CSCC)

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40	Vizimpro	dacomitinib	9/27/2018	To treat metastatic non-small-cell lung cancer
39	Emgality	galcanezumab-gnlm	9/27/2018	For the preventive treatment of migraine in adults
38	Copiktra	duvelisib	9/24/2018	To treat relapd or refractory chronic lymphocytic leukemia, small lymphocytic lymphoma and follicular lymphoma
37	Ajovy	fremanezumab-vfrm	9/14/2018	whitesnake For the preventive treatment of migraine in adults
36	Lumoxiti	moxetumomab pasudotox-tdfk 1998年世界杯主题曲	9/13/2018	brandeisTo treat hairy cell leukemia
35	Pifeltro	doravirine	8/30/2018耶鲁大学公开课下载	To treat HIV-1 infection in adult patients
34	Xerava	eravacycline	8/27/2018	To treat complicated intra-abdominal infections in patients 18 years of age and older
33	Takhzyro	lanadelumab	8/23/2018	To treat types I and II hereditary angioedema
32	Oxervate	cenegermin-bkbj	8/22/2018	To treat neurotrophic keratitis
31	Diacomit	stiripentol	8/20/2018	To treat izures associated with Dravet syndrome in patients 2 years of age and older taking clobazam
30	Galafold	migalastat	8/10/2018	To treat treat adults with Fabry dia.
29	Annovera	gesterone acetate and ethinyl estradiol vaginal system	8/10/2018	一月英语New vaginal ring ud to prevent pregnancy for an entire year
28	Onpattro	patisiran	8/10/2018	To treat the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adult patients
27	Poteligeo	mogamulizumab-kpkc	8/8/2018	To treat two rare types of non-Hodgkin lymphoma
26	Mulpleta	lusutrombopag	7/31/2018	To treat thrombocytopenia in adult patients with chronic liver dia who are scheduled to undergo a procedure
25	Omegaven	fish oil triglycerides	7/27/2018	As a source of calories and fatty acids in pediatric patients with parenteral nutrition-associated cholestasis
24.	Orilissa	elagolix sodium	7/23/2018	For the management of moderate to vere pain associated with endometriosis
23	Krintafel	tafenoquine	7/20/2018	For the radical cure (prevention of relap) of Plasmodium vivax malaria
22	Tibsovo	ivosidenib	7/20/2018	To treat patients with relapd or refractory acute myeloid leukemia
21	TPOXX	tecovirimat	7/13/2018	To treat smallpox

20	Braftovi	encorafenib	6/27/2018	To treat unrectable or metastatic melanoma
19	Mektovi	binimetinib	6/27/2018	To treat unrectable or metastatic melanoma
18	Zemdri	plazomicin	6/25/2018	To treat adults with complicated urinary tract infections
17	Epidiolex	cannabidiol	6/25/2018	To treat rare, vere forms of epilepsy
16	Moxidectin	moxidectin	6/13/2018 考验智商的电影	To treat onchocerciasis due to Onchocerca volvulus in patients aged 12 years and older
15	Olumiant	baricitinib	5/31/2018	To treat moderately to verely active rheumatoid arthritis
14	Palynziq	pegvalia-pqpz	5/24/2018	To treat adults with a rare and rious genetic dia known as phenylketonuria (PKU)
13	Doptelet	avatrombopag	5/21/2018	To treat low blood platelet count (thrombocytopenia) in adults with chronic liver dia who are scheduled to undergo a medical or dental procedure
12	Lokelma	sodium zirconium cyclosilicate	5/18/2018	To treat hyperkalemia
11	Aimovig	erenumab-aooe	5/17/2018	For the preventive treatment for migraine
10	Lucemyra	lofexidine hydrochloride	5/16/2018	For the non-opioid treatment for management of opioid withdrawal symptoms in adults
9.	Akynzeo	fosnetupitant and palonotron	quantity什么意思4/19/2018	To prevent acute and delayed naua and vomiting associated with initial and repeat cours of highly emetogenic cancer chemotherapy
8.	Crysvita	burosumab-twza	4/17/2018	To treat adults and children ages 1 year and older with x-linked hypophosphatemia (XLH), a rare, inherited form of rickets
7.	Tavalis	cover girl fostamatinib	4/17/2018	To treat thrombocytopenia in adult patients with persistent or chronic immune thrombocytopenia (ITP)
6.	Ilumya	tildrakizumab	3/20/2018	To treat adults with moderate-to-vere plaque psoriasis who are candidates for systemic therapy or phototherapy
5.	Trogarzo	ibalizumab-uiyk	3/6/2018	To treat HIV patients who have limited treatment options
4.	Erleada	apalutamide	2/14/2018	To treat a certain type of prostate cancer using novel clinical trial endpoint
3.	Symdeko	tezacaftor; ivacaftor	2/13/2018	To treat cystic fibrosis in patients age 12 years and older
2.	Biktarvy	bictegravir, embitcitabine, tenofovir alafenamide	2/7/2018	To treat infection in adults who have no antiretroviral treatment history or to replace the current antiretroviral regimen
1.	Lutathera	lutetium Lu 177 dotatate	1/26/2018	To treat a type of cancer that affects the pancreas or gastrointestinal tract called gastroenteropancreatic neuroendocrine tumors (GEP-NETs).

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