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(激)素) | 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 |