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US FDA approved novel drugs during 2015-2018

 

1. US FDA approved novel drugs in 2015(45):

No

Drug name

Active   ingredient

Developer

Treatment of   disease

1

Addyi

Flibanserin(氟班色林)

Sprout

To treat cquired,   generalized hypoactive sexual desire disorder (HSDD) in premenopausal women

2

Alecensa

Alectinib(艾乐替尼)

Roche

To treat ALK-positive   lung cancer

3

Aristada

aripiprazole   lauroxil(阿立哌唑兰罗西尔)

Alkermes

To treat adults   with schizophrenia

4

Avycaz

Ceftazidime-avibactam(头孢他啶-阿维巴坦)

Allergan

To treat adults   with complicated intra-abdominal infections (cIAI), in combination with   metronidazole,and complicated urinary tract infections (cUTI),including   kidney infections (pyelonephritis), who have limited or no alternative   treatment options.

5

Bridion

Sugammadex(舒更葡糖)

Merck

To reverse   effects of neuromuscular blocking drugs used during surgery

6

Cholbam

Cholic acid(胆酸)

Asklepion

To treat   pediatric and adult patients with bile acid synthesis disorders due to single   enzyme defects, and for patients with peroxisomal disorders

7

Corlanor

Ivabradine(伊伐布雷定)

Amgen

To reduce   hospitalization from worsening heart failure.

8

Cosentyx

Secukinumab(苏金单抗)

Novartis

To treat adults   with moderate-to-severe plaque psoriasis

9

Cotellic

Cobimetinib(考比替尼)

Roche

To be used in   combination with vemurafenib to treat advanced melanoma that has spread to   other parts of the body or can’t be removed by surgery, and that has a   certain type of abnormal gene (BRAF V600E or V600K mutation)

10

Cresemba

isavuconazonium   sulfate(艾沙康唑硫酸酯)

Basilea

To treat adults   with invasive aspergillosis and invasive mucormycosis, rare but serious   infections

11

Daklinza

Daclatasvir(达卡他韦)

Bristol-Myers   Squibb

To treat chronic   hepatitis C virus (HCV) genotype 3 infections

12

Darzalex

Daratumumab(达雷木单抗)

Johnson &   Johnson

To treat patients   with multiple myeloma who have received at least three prior treatments.

13

Empliciti

Elotuzumab(埃罗妥珠单抗)

Bristol-Myers   Squibb,AbbVie

To treat people   with multiple myeloma who have received one to three prior medications

14

Entresto

Sacubitril/valsartan(沙库必曲/缬沙坦)

Novartis

To treat heart   failure

15

Farydak

Panobinostat(帕比司他)

Novartis

To treat   patients with multiple myeloma

16

Genvoya

Elvitegravir/cobicistat/emtricitabine/   tenofovir alafenamid(埃替格韦/可比司他/恩曲他滨/替诺福韦艾拉酚胺)

Gilead Sciences

For use as a   complete regimen for the treatment of HIV-1 infection in adults and pediatric   patients 12 years of age and older

17

Ibrance

Palbociclib(帕博西尼)

Pfizer

To treat   advanced (metastatic) breast cancer

18

Kanuma

Sebelipase alfa

Alexion

To treat   patients with a rare disease known as

lysosomal acid   lipase (LAL) deficiency

19

Kengreal

Canegrelor(坎格瑞洛)

Medicine’s   Company

To prevent the   formation of harmful blood clots in the coronary arteries for adult patients   undergoing percutaneous coronary intervention

20

Kybella

Deoxycholic acid(去氧胆酸)

Allergan

To treat adults   with moderate-to-severe fat below the chin, known as submental fat

21

Lenvima

Lenvatinib(乐伐替尼)

Eisa ,Merck

To treat   patients with progressive, differentiated thyroid cancer (DTC) whose disease   progressed despite receiving radioactive    odine therapy (radioactive iodine refractory disease).

22

Lonsurf

Trifluridine/tipiracil(曲氟尿苷/替吡嘧啶)

Servier,Taiho

To treat patients   with an advanced form of colorectal cancer who are no longer responding to   other therapies

23

Natpara

parathyroid   horomone(甲状旁腺())

Shire

To control   hypocalcemia (low blood calcium levels) in patients with hypoparathyroidism

24

Ninlaro

Ixazomib(伊沙佐米)

Takeda

To treat people   with multiple myeloma who have received at least one prior therapy

25

Nucala

Mepolizumab(美泊利单抗)

GSK

For use with   other asthma medicines for the maintenance treatment of asthma in patients   age 12 years and older.

26

Odomzo

Sonidegib(索尼吉布)

Novartis

To treat   patients with locally advanced basal cell carcinoma that has recurred   following surgery or radiation therapy, or who are not candidates for surgery   or radiation therapy.

27

Orkambi

Lumacaftor/ivacaftor(鲁玛卡托/依伐卡托)

Vertex

To treat cystic   fibrosis

28

Portrazza

Necitumumab(耐昔妥珠单抗)

Eli Lilly

To treat   patients with advanced (metastatic) squamous non-small cell lung cancer   (NSCLC) who have not previously received medication specifically for treating   their advanced lung cancer

29

Praluent

Alirocumab(阿莫罗布单抗)

Regeneron,Sanofi

To treat certain   patients with high cholesterol

30

Praxbind

Idarucizumab(依达赛珠单抗)

Boehringer   Ingelheim

For use in   patients who are taking the anticoagulant Pradaxa (dabigatran) during   emergency situations when there is a need to reverse Pradaxa’s bloodthinning   effects.

31

Repatha

Evolocumab(依伏库人单抗)

Amgen

To treat certain   patients with high cholesterol

32

Rexulti

Brexpiprazole(依匹哌唑)

H.Lundbeck,   Otsuka

To treat   schizophrenia and as an add on to an antidepressant to treat major depressive   disorder

33

Savaysa

Edoxaban(依度沙班)

Daiichi Sankyo

oral   anticoagulant

34

Strensiq

Asfotase alfa

Alexion

To treat   perinatal, infantile and juvenile-onset hypophosphatasia (HPP).

35

Tagrisso

Osimertinib(奥希替尼)

AstraZeneca

To treat certain   patients with non-small cell lung cancer

36

Tresiba

Insulin degludec(德谷胰岛素)

Novo Nordisk

To improve blood   sugar (glucose) control in adults with diabetes mellitus

37

Unituxin

Dinutuximab

United therapeutics

To treat   pediatric patients with high-risk neuroblastoma

38

Uptravi

Selexipag(赛乐西帕)

Actelion

To treat   pulmonary arterial hypertension

39

Varubi

Rolapitant(罗拉匹坦)

Tesaro

To prevent   delayed phase chemotherapy-induced nausea and vomiting (emesis)

40

Veltassa

Patiromer for   oral suspension

Vifor

To treat   hyperkalemia, a serious condition in which the amount of potassium in the   blood is too high.

41

Viberzi

Eluxadoline(艾沙度林)

Forest

To treat   irritable bowel syndrome with diarrhea (IBS-D) in adult men and women.

42

Vraylar

Cariprazine(卡利拉嗪)

Allergan

To treat   schizophrenia and bipolar disorder in    adults

43

Xuriden

Uridine   triacetate(尿苷三乙酸酯)

Wellstat

To treat   patients with hereditary orotic aciduria

44

Yondelis

Trabectedin(曲贝替定)

Johnson &   Johnson

To treat   specific soft tissue sarcomas (STS) –liposarcoma and leiomyosarcoma – that   cannot be removed by surgery unresectable) or is advanced (metastatic).

45

Zurampic

Lesinurad(雷西纳德)

AstraZeneca

To treat high   blood uric acid levels associated with gout

 

2. US FDA approved novel drugs in 2016(22):

No

Drug name

Active   ingredient

Developer

Treatment of   disease

1

Adlyxin

Lixisenatide(利西拉肽)

Sanofi

To improve   glycemic control (blood sugar levels)

2

Anthim

Obiltoxaximab

Elusys

To treat inhalational   anthrax in combination with appropriate antibacterial drugs.

3

Axumin

Fluciclovine   F-18

Blue Earth

A new diagnostic   imaging agent to detect recurrent prostate cancer

4

Briviact

Brivaracetam(布瓦西坦)

UCB

To treat partial   onset seizures in patients age 16 years and older with epilepsy.

5

Cinqair

Reslizumab(瑞利珠单抗)

Teva

To treat severe   asthma

6

Defitelio

defibrotide   sodium(去纤核苷酸钠)

Jazz Pharma

To treat adults   and children who develop hepatic veno-occlusive disease with additional   kidney or lung abnormalities after they receive a stem cell transplant from   blood or bone marrow called hematopoietic stem cell transplantation

7

Epclusa

Sofosbuvir/velpatasvir(索非布韦/维帕他韦)

Gilead Sciences

To treat all six   major forms of hepatitis C virus

8

Eucrisa

Crisaborole

Anacor

To treat mild to   moderate eczema (atopic dermatitis) in patients two years of age and older

9

Exondys

Eteplirsen

Sarepta

To treat   patients with Duchenne muscular dystrophy

10

Lartruvo

Olaratumab(奥拉单抗)

Eli Lilly

To treat adults   with certain types of soft tissue sarcoma

11

Netspot

Gallium Ga 68   dotatate

Advanced   Accelerator Applications

A diagnostic   imaging agent to detect rare neuroendocrine tumors

12

Nuplazid

Pimavanserin(匹莫范色林)

Acadia

To treat   hallucinations and delusions associated with psychosis experienced by some   people with Parkinson’s disease

13

Ocaliva

Obeticholic acid(奥贝胆酸)

Intercept

To treat rare,   chronic liver disease known as primary biliary cirrhosis

14

Rubraca

Rucaparib(瑞卡帕布)

Clovis

To treat women   with a certain type of ovarian cancer

15

Spinraza

Nusinersen

Biogen

To treat   children and adults with spinal muscular atrophy (SMA)

16

Taltz

Ixekizumab

Eli Lilly

To treat adults   with moderate-to-severe plaque psoriasis.

17

Tecentriq

Atezolizumab(阿特珠单抗)

Roche

To treat   urothelial carcinoma, the most common type of bladder cancer

18

Venclexta

Venetoclax

Roche

For chronic   lymphocytic leukemia in patients with a specific chromosomal abnormality

19

Xiidra

Lifitegrast(立他司特)

Shire

To treat the   signs and symptoms of dry eye disease

20

Zepatier

Elbasvir/grazoprevir

Merck

To treat   patients with chronic hepatitis C virus (HCV) genotypes 1 and 4 infections in   adult patients.

21

Zinbryta

Daclizumab(达利珠单抗)

Biogen,AbbVie

To treat   multiple sclerosis

22

Zinplava

Bezlotoxumab

Merck

To reduce the   recurrence of Clostridium difficile infection in patients aged 18 years or   older

 

3. US FDA approved novel drugs in 2017(46):

No

Drug name

Active   ingredient

Developer

Treatment of   disease

1

Aliqopa

Copanlisib

Bayer

To treat adults   with relapsed follicular lymphoma

2

Alunbrig

Brigatinib(布吉替尼)

Ariad

For ALK+   Metastatic Non-Small Cell Lung Cancer (NSCLC)

3

Austedo 

Deutetrabenazine

Teva

For the   treatment of chorea associated with Huntington's disease

4

Bavencio

Avelumab

Merck,Pfizer

For the   treatment of patients 12 years and older with a rare and aggressive form of   cancer called metastatic Merkel cell carcinoma, including those who have not   received prior chemotherapy;

5

Baxdela 

Delafloxacin(德拉沙星)

Melinta  

For the treatment   of ABSSSI caused by susceptible gram -/+ pathogens, including MRSA.

6

benznidazole

Benznidazole(苄硝唑)

Chemo Research

To treat   children ages 2 to 12 years with Chagas disease

7

Besponsa 

inotuzumab   ozogamicin(依托珠单抗奥佐米星)

Pfizer

For the   treatment of adults with a type of cancer of the blood called relapsed or   refractory B-cell precursor acute lymphoblastic leukemia

8

Bevyxxa 

Betrixaban(贝曲西班)

Portola

An oral   anticoagulant

9

Brineura

Cerliponase alfa

BioMarin

Enzyme   replacement therapy that helps treat CLN2 disease, a common form of Batten   disease

10

Calquence 

Acalabrutinib

AstraZeneca

To treat adults   with mantle cell lymphoma who have received at least one prior therapy

11

Dupixent 

Dupilumab

Regeneron,Sanofi

For adult   patients with uncontrolled, moderate-to-severe eczema (atopic dermatitis).

12

Emflaza

Deflazacort(地夫可特)

Marathon

To treat   patients age 5 years and older with Duchenne muscular dystrophy

13

Fasenra 

Benralizumab

AstraZeneca

Add-on   maintenance treatment for patients 12 and older who are diagnosed with severe   eosinophilic asthma

14

Giapreza 

Angiotensin II(血管紧张素II)

Jolla

For the   treatment of hypotension in adults with distributive or vasodilatory shock

15

Hemlibra

Emicizumab-kxwh

Roche

A hemophilia A   treatment approved for people with hemophilia A with or without factor VIII   inhibitors

16

Idhifa 

Enasidenib(恩西地平)

Celgene, Agios

For the   treatment of adults with relapsed or refractory acute myeloid leukemia

17

Imfinzi 

Durvalumab

AstraZeneca

Treatment for   people with unresectable Stage 3 non-small cell lung cancer (NSCLC)

18

Ingrezza

Valbenazine

Neurocrine   Biosciences

To treat adults   with tardive dyskinesia

19

Kevzara 

Sarilumab

Regeneron,Sanofi

Treatment for   adults with moderately to severely active rheumatoid arthritis after DMARD   intolerance or failure

20

Kisqali 

Rbociclib

Astex,novartis

The first and   only medication of its kind indicated specifically for premenopausal women   with HR+, HER2- metastatic breast cancer.

21

Macrilen

Macimorelin(马西瑞林)

Aeterna Zentaris

To treat giagnosis   of Adult Growth Hormone Deficiency

22

Mavyret 

Glecaprevir/pibrentasvir

AbbVie

To treat adults   with chronic hepatitis C virus genotypes 1-6 without cirrhosis (liver   disease) or with mild cirrhosis, including patients with moderate to severe   kidney disease, as well as those who are on hemodialysis

23

Mepsevii 

Vestronidase   alfa-vjbk

Ultragenyx

To treat   patients with Sly syndrome or mucopolysaccharidosis type 7

24

Nerlynx

Neratinib(来那替尼)

Puma

For the extended   adjuvant treatment of early-stage, human epidermal growth factor receptor 2   (HER2)-positive breast cancer

25

Ocrevus 

Ocrelizumab(奥美珠单抗)

Roche

To treat adults   with relapsing or primary progressive forms of multiple sclerosis

26

Ozempic 

Semaglutide(索马鲁肽)

Novo Nordisk

Once-a-week   GLP-1 RA injection for adults with type 2 diabetes

27

Parsabiv

Etelcalcetide(维拉卡肽)

Amgen

Treatment for   secondary HPT in adult patients with chronic kidney disease (CKD) on   hemodialysis

28

Prevymis 

Letermovir(乐特莫韦)

Merck

For prevention   of an infection called cytomegalovirus (CMV) in patients who are receiving a   bone marrow transplant

29

Radicava 

Edaravone(依达拉奉)

Mitsubishi   Tanabe

To treat   patients with amyotrophic lateral sclerosis, commonly referred to as Lou   Gehrig’s disease

30

Rhopressa

Netarsudil

Aerie

To lower eye   pressure in patients with open-angle glaucoma and ocular hypertension

31

Rydapt

Midostaurin(米哚妥林)

Novartis

To treat adults   newly diagnosed with a form of blood cancer known as acute myeloid leukemia   who have a specific genetic mutation called FLT3

32

Siliq 

Brodalumab

Valeant

To treat adults   with moderate-to-severe plaque psoriasis

33

Solosec 

Secnidazole(塞克硝唑)

Symbiomix

To treat   bacterial vaginosis in adult women

34

Steglatro 

Ertugliflozin(埃格列净)

Merck,Pfizer

Treatment of type   2 diabetes

35

Symproic 

Naldemedine

Shionogi,Purdue

For the   treatment of opioid-induced constipation in adults with chronic noncancer   pain

36

Tremfya

Guselkumab

Johnson &   Johnson

For the   treatment of adults with moderate-to-severe plaque psoriasis

37

Trulance 

Plecanatide(普卡那肽)

Synergy

To treat adults   with chronic idiopathic constipation

38

Tymlos 

Abaloparatide(阿巴帕肽)

Radius

Treatment of   postmenopausal women with osteoporosis

39

Vabomere 

Vaborbactam/meropenem(Vaborbactam/美罗培南)

The Medicines   Company

For treatment of   adults with complicated urinary tract infections, including pyelonephritis   (kidney infection) caused by bacteria

40

Verzenio 

Abemaciclib(阿贝西利)

Eli Lilly

To treat adults   who have hormone receptor (HR)-positive, HER2-negative advanced or metastatic   breast cancer that has progressed after taking therapy that alters a   patient’s hormones (endocrine therapy)

41

Vosevi 

Sofosbuvir/velpatasvir/voxilaprevir(索非布韦/维帕他韦/伏西瑞韦)

Gilead

To treat adults   with chronic hepatitis C virus genotypes 1-6 without cirrhosis (liver   disease) or with mild cirrhosis

42

Vyzulta

latanoprostene   bunod(拉坦前列腺素)

Bausch+Lomb

Treatment of   ocular hypertension and open angle glaucoma

43

Xadago 

Safinamide(沙芬酰胺)

Newron

Add-on treatment   for patients with Parkinson’s disease who are currently taking   levodopa/carbidopa and experiencing “off” episodes

44

Xermelo 

Telotristat   ethyl

Lexicon

Combined with   somatostatin analog (SSA) therapy to treat adults with carcinoid syndrome   diarrhea that SSA therapy alone has inadequately controlled

45

Xepi 

Ozenoxacin(奥泽沙星)

Medimetriks

Treatment of   impetigo

46

Zejula

Niraparib(尼拉帕尼)

Tesaro,Merck

For the   maintenance treatment of women with recurrent ovarian cancer.

 

4. US FDA approved novel drugs in 2018(59):

No

Drug name

Active   ingredient

Developer

Treatment of   disease

1

Aemcolo 

Rifamycin(利福霉素)

Cosmo

For the   treatment of adult patients with travelers' diarrhea

2

Aimovig 

Erenumab

Novartis,Amgen

Preventive   treatment of migraine

3

Ajovy

Fremanezumab-vfrm

Teva

Preventive   treatment of migraine

4

Akynzeo 

Netupitant/palonosetron(奈妥吡坦/帕洛诺司琼)

Helsinn  

For the prevention   of Chemotherapy-Induced Nausea and Vomiting (CINV)

5

Annovera

Segesterone   acetate and ethinyl estradiol

TherapeuticsMD

A vaginal ring   that can be used for birth control for one year

6

Asparlas

Calaspargase   pegol-mknl

Servier

To treat Acute   Lymphoblastic Leukemia

7

Biktarvy

Bictegravir/emtricitabine/   tenofovir alafenamide(Bictegravi/恩曲他滨/替诺福韦艾拉酚胺)

Gilead Sciences

To treat HIV-1   in adults

8

Braftovi

Encorafenib

Array BioPharma

To treat people   with advanced melanoma

9

Copiktra

Duvelisib

Verastem

For the   treatment relapsed or refractory chronic lymphocytic leukaemia/small   lymphocytic lymphoma

10

Crysvita

Burosumab

Ultragenyx, Kyowa Kirin

For the   treatment of X-linked hypophosphatemia (XLH)

11

Daurismo

Glasdegib

Pfizer

For the   treatment of newly-diagnosed acute myeloid leukemia in adults 75 years of age   or older

12

Diacomit

Stiripentol(司替戊醇)

Biocodex

For the   treatment of seizures associated with Dravet syndrome (DS) in patients 2   years of age and older

13

Doptelet

Avatrombopag

AkaRx,Dova

For the   treatment of thrombocytopenia in adult

14

Elzonris

Tagraxofusp

Stemline

For the   treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults   and in pediatric patients, two years of age and older.

15

Emgality

Galcanezumab-gnlm

Eli Lilly

For the   preventive treatment of migraine in adults

16

Epidiolex

Cannabidiol(大麻二醇)

GW   Pharmaceuticals

For the   treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet   syndrome (DS) in patients 2 years of age and older

17

Erleada

Apalutamide

Johnson &   Johnson

To treat   nonmetastatic castration-resistant prostate cancer

18

Firdapse

Amifampridine

Catalyst Pharma

To treat Lambert   Eaton Myasthenic Syndrome

19

Galafold

Migalastat

Amicus

For the   treatment of Fabry disease

20

Gamifant

Emapalumab

Novimmune  

To treat   Hemophagocytic Lymphohistiocytosis

21

Ilumya

Tildrakizumab-asmn

Sun Pharma

To treat adults   with moderate-to-severe plaque psoriasis

22

Krintafel

Tafenoquine(他非诺喹)

GSK

For prevention   of relapse of vivax malaria

23

Libtayo

Cemiplimab-rwlc

Sanofi ,Regeneron

To treat people   with advanced squamous cell carcinoma of the skin

24

Lokelma

Sodium zirconium   cyclosilicate(环硅酸锆钠)

AstraZeneca

For the   treatment of hyperkalaemi

25

Lorbrena

Lorlatinib(劳拉替尼)

Pfizer

To treat people   with non-small cell lung cancer (NSCLC)

26

Lucemyra

Lofexidine(洛非西定)

US WorldMeds

For the treatment   for relief of multiple symptoms of opioid withdrawal after abrupt   discontinuation in adults.

27

Lumoxiti

Moxetumomab   pasudotox-tdfk

AstraZeneca

For the   treatment of adult patients with relapsed or refractory hairy cell leukemia

28

Lutathera

Lutetium Lu 177   dotatate

Advanced   Accelerator Applications

for treatment of   Gastroenteropancreatic Neuroendocrine Tumors

29

Mektovi

Encorafenib

Array BioPharma

For treating   melanoma (a skin cancer)

30

Motegrity

Prucalopride(普芦卡必利)

Shire  

For the   treatment of adults with chronic idiopathic constipation

31

Moxidectin

Moxidectin(莫西菌素)

MDGH

For the   treatment of river blindness in patients older than 12 years

32

Mulpleta

Lusutrombopag(鲁索曲波帕)

Shionogi

For the   treatment of thrombocytopenia in adult patients with chronic liver disease

33

Nuzyra

Omadacyclin

Paratek

For treating   adults with community-acquired bacterial pneumonia and acute skin and skin   structure infections

34

Olumiant

Baricitinib(巴瑞克替尼)

Eli Lilly

For the   treatment of adult patients with moderately to severely active rheumatoid   arthritis

35

Omegaven

Fish oil   triglycerides(鱼油甘油三酯)

Fresenius Kabi

To provide   calories and fatty acids for pediatric patients with parenteral   nutrition-associated cholestasis (PNAC)

36

Onpattro

Patisiran

Alnylam

To treat the   polyneuropathy caused by an illness called hereditary transthyretin-mediated   amyloidosis (hATTR amyloidosis)

37

Orilissa

Elagolix

AbbVie, Neurocrine

To treat 3   common endometriosis symptoms: painful periods, pelvic pain in between   periods, and pain with sex

38

Oxervate

Cenegermin

Dompe

For treatment of   neurotrophic keratitis

39

Palynziq

Pegvaliase-pqpz

BioMarin

For the   treatment of phenylketonuria (PKU) in adults

40

Pifeltro

Doravirine

Merck

For the   treatment of HIV-1 infection in adult

41

Poteligeo

Mogamulizumab-kpkc

Kyowa Kirin

For the   Treatment of Mycosis Fungoides and Sézary Syndrome

42

Revcovi

Elapegademase-lvlr

Leadiant  

For the   treatment of adenosine deaminase severe combined immune deficiency (ADA-SCID)

43

Seysara

Sarecycline

Allergan,Paratek  

For the   Treatment of Moderate to Severe Acne

44

Symdeko

Tezacaftor/ivacaftor

Vertex Pharma

To treat cystic   fibrosis (CF) in people ages 12 years and older

45

Takhzyro

Lanadelumab-flyo

Shire

For the   preventive treatment of hereditary angioedema (HAE) in patients aged 12 years   and older

46

Talzenna

Talazoparib(他拉唑帕尼)

Pfizer

To treat locally   advanced or metastatic HER2-negative breast cancer in women

47

Tavalisse

Fostamatinib

Rigel

To treat chronic   immune thrombocytopenia

48

Tegsedi

Inotersen

Akcea,Ionis

For the   treatment of adults with polyneuropathy of hereditary transthyretin-mediated   amyloidosis (hATTR)

49

Tibsovo

Ivosidenib

Agios

Treatment option   for patients with acute myeloid leukemia (AML) and an IDH1 mutation

50

TPOXX

Tecovirimat

SIGA   Technologies

For the treatment   of smallpox

51

Trogarzo

Ibalizumab-uiyk

Theratechnologies

For the   treatment of multidrug-resistant HIV-1 infection

52

Ultomiris

Ravulizumab

Alexion

Treatment option   for adult patients living with paroxysmal nocturnal hemoglobinuria (PNH)

53

Vitrakvi

Larotrectinib(拉罗替尼)

Bayer,Loxo

Treatment for   adult and pediatric patients whose cancers have a specific genetic feature   (biomarker)

54

Vizimpro

Dacomitinib(达克替尼)

Pfizer

To treat   non-small cell lung cancer (NSCLC)

55

Xerava

Eravacycline

Tetraphase

For the   treatment of complicated intra-abdominal infections in patients 18 years of age   and older

56

Xofluza

Baloxavir   marboxil

Shionogi,Roche

To treat the flu

57

Xospata

Gilteritinib

Astellas

For the   treatment of adult patients who have relapsed or refractory acute myeloid   leukemia

58

Yupelri

Revefenacin(依伐卡托)

Theravance,Mylan

For the   maintenance treatment of chronic obstructive pulmonary disease

59

Zemdri

Plazomicin

Achaogen

For the   treatment of complicated urinary tract infections (cUTI), including   pyelonephritis