FDA New Molecular Entities [2011-November 2024] 第4頁(末)

  Drug Name Active Ingredient Combo/single ATC Index AHFS Class Date of Approval Mechanism Treatment TFDA approval
515 Jeuveau prabotulinumtoxinA-xvfs Single M03AX01 92:92 2019/2/13 acetylcholine release inhibitor For the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients 　
516 Daxxify daxibotulinumtoixnA-lanm Single M03AX01 92:92 2022/9/7 botulinum toxin A To treat moderate-to-severe glabellar lines associated with corrugator and/or procerus muscle activity 　
517 Voxzogo vosoritide Single M05BX07 92:92 2021/11/19 MAPK-ERK pathway inhibitor To improve growth in children five years of age and older with achondroplasia and open epiphyses 　
518 Exondys 51 eteplirsen Single M09AX06 92:92 2016/10/21 binds exon 51 of dystrophin gene to exclude it during mRNA processing To treat patients with Duchenne muscular dystrophy 　
519 Spinraza nusinersen Single M09AX07 92:92 2017/2/7 increases splicing efficiency of SMN2 pre-mRNA to increase SMN expression To treat children and adults with spinal muscular atrophy (SMA) 　
520 Evrysdi risdiplam Single M09AX10 92:92 2020/8/12 increase SMN2 protein production To treat spinal muscular atrophy 　
521 Sohonos palovarotene Single M09AX11 92:92 2023/8/16 retinoic acid receptor-gamma (RAR-γ) agonist To reduce the volume of new heterotopic ossification in adults and pediatric patients (aged 8 years and older for females and 10 years and older for males) with fibrodysplasia ossificans progressiva 　
522 Duvyzat givinostat Single M09AX14 92:92 2024/3/21 histone deacetylase inhibitor To treat Duchenne muscular dystrophy in individuals aged 6 years and older 　
523 Firdapse amifampridine Single N07XX05 92:92 2018/12/14 voltage-gated K+ channel inhibitor To treat Lambert-Eaton myasthenic syndrome (LEMS) in adults 　
524 Onpattro patisiran Single N07XX12 92:92 2018/8/10 degrades TTR mRNA through RNA interference To treat the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adult patients 　
525 Amvuttra vutrisiran Single N07XX18 92:92 2022/6/13 siRNA-GalNAc conjugate To treat polyneuropathy of hereditary transthyretin-mediated amyloidosis 　
526 Skyclarys omaveloxolone Single N07XX25* 92:92 2023/2/28 Nfr2 pathway activator To treat Friedrich’s ataxia 　
527 Aqneursa levacetylleucine Single 　 92:92 2024/9/24 Acetylated derivative of leucine To treat Niemann-Pick disease type C 　
528 Niktimvo axatilimab-csfr Single 　 92:92 2024/8/14 mab, CSF-1R To treat chronic graft-versus-host disease (cGVHD) 　
529 Brenzavvy bexagliflozin Single A10BK08 　 2023/1/20 SGLT2 inhibitor To improve glycemic control in adults with type 2 diabetes mellitus as an adjunct to diet and exercise 　
530 Gattex teduglutide Single A16AX08 　 2012/12/28 　 To treat adults with short bowel syndrome (SBS) who need additional nutrition from intravenous feeding (parenteral nutrition). 　
531 Eliquis apixaban Single B01AF02 　 2012/12/31 　 To reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation that is not caused by a heart valve problem. 　
532 Juxtapid lomitapide Single C10AX12 　 2012/12/28 　 To reduce low-density lipoprotein (LDL) cholesterol, total cholesterol, apolipoprotein B, and non-high-density lipoprotein (non-HDL) cholesterol in patients with homozygous familial hypercholesterolemia (HoFH). 　
533 Nextstellis drospirenone, estetrol Combo G03AA18 　 2021/4/23 suppressing ovulation To prevent pregnancy 　
534 Sirturo bedaquiline Single J04AK05 　 2013/1/25 　 As part of combination therapy to treat adults with multi-drug resistant pulmonary tuberculosis (TB) when other alternatives are not available. 　
535 raxibacumab raxibacumab Single J06BC02 　 2012/12/21 　 To treat inhalational anthrax, a form of the infectious disease caused by breathing in the spores of the bacterium Bacillus anthracis. 　
536 Bosulif bosutinib Single L01EA04 　 2012/9/12 　 To treat chronic myelogenous leukemia (CML), a blood and bone marrow disease that usually affects older adults. 　
537 Iclusig ponatinib Single L01EA05 　 2012/12/14 　 To treat adults with chronic myeloid leukemia (CML) and Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), two rare blood and bone marrow diseases. 　
538 Exkivity mobocertinib Single L01EB10 　 2021/9/15 EGFR Exon20 insertion inhibitor To treat locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations 　
539 Cometriq cabozantinib Single L01EX07 　 2012/12/14 　 To treat medullary thyroid cancer that has spread to other parts of the body (metastasized). 　
540 Ziihera zanidatamab-hrii Single L01FD07* 　 2024/11/20 bispecific mab, 2 HER2 epitopes To treat unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer 　
541 Synribo omacetaxine mepesuccinate Single L01XX40 　 2012/11/29 　 To treat adults with chronic myelogenous leukemia (CML), a blood and bone marrow disease. 　
542 Xtandi enzalutamide Single L02BB04 　 2012/9/12 　 To treat men with late-stage (metastatic) castration-resistant prostate cancer that has spread or recurred, even with medical or surgical therapy to minimize testosterone. 　
543 Xeljanz tofacitinib Single L04AF01 　 2012/12/14 　 To treat adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to, or who are intolerant of, methotrexate. 　
544 Aubagio teriflunomide Single L04AK02 　 2012/9/27 　 For the treatment of adults with relapsing forms of multiple sclerosis (MS). 　
545 Fycompa perampanel Single N03AX22 　 2012/11/6 　 To treat partial onset seizures in patients with epilepsy ages 12 years and older. 　
546 Jetrea ocriplasmin Single S01XA22 　 2012/10/26 　 To treat an eye condition called symptomatic vitreomacular adhesion (VMA). 　
547 Xalkori crizotinib Single 　 　 2011/10/24 ALK inhibitor To treat certain patients with late-stage (locally advanced or metastatic), non-small cell lung cancers (NSCLC) who express the abnormal anaplastic lymphoma kinase (ALK) gene. 　
548 Natroba spinosad Single 　 　 2011/1/18 alters nicotinic acetylcholine receptors, leading to lice paralysis and death For the treatment of head lice infestation in patients ages 4 years and older. 　
549 Dificid fidaxomicin Single 　 　 2011/6/15 bacterial RNA synthesis inhibitor For the treatment of Clostridium difficile-associated diarrhea (CDAD). 　
550 Arcapta Neohaler indacaterol inhalation powder Single 　 　 2011/7/20 beta2-adrenergic agonist For the long term, once-daily maintenance bronchodilator treatment of airflow obstruction in people with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema. 　
551 Firazyr icatibant Single 　 　 2011/10/14 bradykinin B2 antagonist For the treatment of acute attacks of a rare condition called hereditary angioedema (HAE) in people ages 18 years and older. 　
552 Xarelto rivaroxaban Single 　 　 2011/8/17 FXa inhibitor To reduce the risk of blood clots, deep vein thrombosis (DVT), and pulmonary embolism (PE) following knee or hip replacement surgery. 　
553 Potiga ezogabine Single 　 　 2011/7/1 Kv7.2-7.5 voltage activated K channels opener For use as an add-on medication to treat seizures associated with epilepsy in adults. 　
554 Adcetris brentuximab vedotin Single 　 　 2011/8/26 mab, CD30 For the treatment of Hodgkin lymphoma and ALCL (systemic anaplastic large cell lymphoma). 　
555 Zelboraf vemurafenib Single 　 　 2011/8/25 mutant BRAF V600E kinase inhibitor To treat patients with late-stage (metastatic) or unresectable (cannot be removed by surgery) melanoma, the most dangerous type of skin cancer. 　
556 Victrelis boceprevir Single 　 　 2011/5/13 NS3/4A protease inhibitor To treat certain adults with chronic hepatitis C. 　
557 Incivek telaprevir Single 　 　 2011/6/10 NS3/4a protease inhibitor against HCV replication To treat certain adults with chronic hepatitis C infection. 　
558 Brilinta ticagrelor Single 　 　 2011/8/19 P2Y12 antagonist To reduce cardiovascular death and heart attack in patients with acute coronary syndromes (ACS). 　
559 Datscan ioflupane i-123 Single 　 　 2011/1/14 reversibly binds DaT An imaging drug used to assist in the evaluation of adult patients with suspected Parkinsonian syndromes (PS). 　
560 Horizant gabapentin enacarbil Single 　 　 2011/4/6 selective inhibitory effect on voltage-gated Ca channels with alpha-2-delta-1 subunit A once-daily treatment for moderate-to-severe restless legs syndrome (RLS). 　
561 Nulojix belatacept Single 　 　 2011/7/1 selective T-cell (lymphocyte) costimulation blocker To prevent acute rejection in adult patients who have had a kidney transplant. 　
562 Viibryd vilazodone hydrochloride Single 　 　 2011/1/21 serotonin transporter inhibitor To treat major depressive disorder in adults. 　
563 Gadavist gadobutrol Single 　 　 2011/3/14 shortens T1 and T2 relaxation times For use in patients undergoing magnetic resonance imaging (MRI) of the central nervous system. 　
564 Eylea aflibercept Single 　 　 2012/1/23 soluble protein decoy that binds VEGF-A and PIGF To treat patients with wet (neovascular) age-related macular degeneration (AMD), a leading cause of vision loss and blindness in Americans ages 60 and older. 　
565 Edarbi azilsartan medoxomil Single 　 　 2011/2/25 stimulates aldosterone synthesis and release; promotes renal Na reabsorption To treat high blood pressure (hypertension) in adults. 　
566 Caprelsa vandetanib Single 　 　 2011/4/6 VEGF and EGF RTK inhibitor To treat adult patients with late-stage (metastatic) medullary thyroid cancer who are ineligible for surgery and who have disease that is growing or causing symptoms. 　
567 Voraxaze glucarpidase Single 　 　 2012/1/27 　 To treat patients with toxic levels of methotrexate in their blood due to kidney failure. 　
568 Picato ingenol mebutate Single 　 　 2012/1/30 　 For the topical treatment of actinic keratosis. 　
569 Inlyta axitinib Single 　 　 2012/1/31 　 To treat patients with advanced kidney cancer (renal cell carcinoma) who have not responded to another drug for this type of cancer. 　
570 Erivedge vismodegib Single 　 　 2012/2/10 　 To treat adult patients with basal cell carcinoma, the most common type of skin cancer. 　
571 Zioptan tafluprost Single 　 　 2012/3/27 　 For reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. 　
572 Surfaxin lucinactant Single 　 　 2012/4/6 　 For the prevention of respiratory distress syndrome (RDS), a breathing disorder that affects premature infants. 　
573 Omontys peginesatide Single 　 　 2012/4/27 　 To treat anemia, a condition in which the body does not have enough healthy red blood cells, in adult dialysis patients who have chronic kidney disease (CKD). 　
574 Amyvid Florbetapir F 18 Single 　 　 2012/5/1 　 Used as a radioactive diagnostic agent for Positron Emission Tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer’s Disease (AD) and other causes of cognitive decline. 　
575 Stendra avanafil Single 　 　 2012/6/8 　 To treat erectile dysfunction. 　
576 Elelyso taliglucerase alfa Single 　 　 2012/6/27 　 For long-term enzyme replacement therapy to treat a form of Gaucher disease, a rare genetic disorder 　
577 Myrbetriq mirabegron Single 　 　 2012/7/20 　 To treat adults with overactive bladder. 　
578 Prepopik sodium picosulfate, magnesium oxide and citric acid Combo 　 　 2012/7/23 　 To help cleanse the colon in adults preparing for colonoscopy. 　
579 Kyprolis carfilzomib Single 　 　 2012/8/3 　 To treat patients with multiple myeloma who have received at least two prior therapies, including treatment with Velcade (bortezomib) and an immunomodulatory. 　
580 Tudorza Pressair aclidinium bromide Single 　 　 2012/8/27 　 For the long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. 　
581 Zaltrap ziv-aflibercept Single 　 　 2012/8/29 　 For use in combination with a FOLFIRI (folinic acid, fluorouracil and irinotecan) chemotherapy regimen to treat adults with colorectal cancer. 　
582 Stribild elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate Combo 　 　 2012/8/30 　 A once-a-day combination pill to treat HIV-1 infection in adults who have never been treated for HIV infection. 　
583 Neutroval tbo-filgrastim Single 　 　 2012/8/31 　 To reduce the time certain patients receiving cancer chemotherapy experience severe neutropenia, a decrease in infection-fighting white blood cells called neutrophils. 　
584 Linzess linaclotide Single 　 　 2012/9/4 　 To treat chronic idiopathic constipation and to treat irritable bowel syndrome with constipation (IBS-C) in adults. 　
585 Choline C 11 Injection Choline C 11 Injection Single 　 　 2012/10/17 　 A Positron Emission Tomography (PET) imaging agent used to help detect recurrent prostate cancer. 　
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