2010及2011年FDA批准新药

更新时间:2023-06-08 07:13:16 阅读: 评论:0

New Molecular Entities/Significant Biologicals – 2010
Brand/Generic
结构
Company
Description
Actemra
tocilizumab
抗人白介素-6受体单克隆抗体
Genentech
An interleukin-6 inhibitor for moderate to vere rheumatoid arthritis.
治疗中-重度风湿性关节炎。
首个获准治疗该病的白介素6受体抑制类单克隆抗体药物,可单独使用,也可以和甲氨蝶呤或其他缓解类抗风湿药联用。 
Ampyra
dalfampridine
Acorda Therap.
A potassium channel blocker to improve walking in patients with multiple。
提高多发性硬化症患者的步度
Asclera
polidocanol
聚多卡醇注射剂
BioForm Medical
An injectable agent for small varico veins (spider veins and reticular veins)
治疗小血管静脉曲张
Carbaglu
carglumic acid
CAS number1188-38-1
Orphan Europe
A CPS 1 activator for elevated ammonia levels due to N-acetylglutamate syntha deficiency.
用于治疗高氨血症——罕见的常染色体遗传性疾病
Cysview
hexaminolevulinate
Photocure ASA
An optical imaging agent for bladder instillation to detect bladder cancer.
造影剂Cysview用于非肌肉侵入性乳头状膀胱癌的检查
Egrifta
tesamorelin
EMD Serono
A growth hormone releasing factor for HIV-associated lipodystrophy.
用于治疗艾滋病(AIDS)患者脂肪代谢障碍
Ella
ulipristal
选择性孕酮受体调节剂
素描风景画
CAS number:126784-99-4
Watson
A progesterone agonist/antagonist emergency contraceptive.
紧急避孕药
Gilenya
fingolimod
CAS number162359-55-9
Novartis
An oral sphingosine 1-phosphate receptor modulator to reduce relaps and delay disability progression in certain patients with multiple sclerosis.
多发性硬化症治疗药
Glassia
alpha1-proteina inhibitor
α1-人蛋白酶抑制剂
Kamada
红色娘子军歌词Replacement therapy for patients with emphyma due to deficiency of alpha1-proteina inhibitor.
治疗肺气肿
Halaven
eribulin
CAS number253128-41-5
Eisai
A microtubule inhibitor for metastatic breast cancer.
乳腺癌新型化疗药-Halaven(甲磺酸艾日布林注射剂)
Jevtana
cabazitaxel
CAS number183133-96-2
Sanofi-aventis
A microtubule inhibitor for advanced prostate cancer.
韩国简介用于前列腺癌
Krystexxa
peglotica
CAS number885051-90-1
Savient
A uric acid-specific enzyme for chronic refractory gout.
治疗慢性痛风
Lastacaft
alcaftadine
Vistakon Pharma.
An ophthalmic antihistamine for allergic conjunctivitis.
用于过敏性结膜炎
Latuda
lurasidone
盐酸鲁拉西酮
CAS number367514-87-2
Sunovion Pharma.
An atypical antipsychotic for schizophrenia.
治疗精神分裂
Lumizyme
alglucosida alfa
阿葡糖苷酶α
CAS number420794-05-0
Genzyme
An enzyme needed for muscle function with late-ont Pompe dia.
用于8岁及以上儿童的迟发性庞贝氏症
Menveo
meningococcal vaccine
Novartis
A vaccine to prevent meningococcal dia caud by Neisria meningitidis rogroups A, C, Y, and W-135 in persons 11 to 55 years of age.
针对4种常见型细菌性脑膜炎疫苗
Natazia
estradiol valerate/ dienogest
Bayer HealthCare
A four-phasic, 28-day oral contraceptive with two placebo tablets.
避孕药
Pradaxa
dabigatran
元宵节翻译达比加群酯
Boehringer Ingelheim
A direct thrombin inhibitor for prevention of stroke in patients with atrial fibrillation.
预防中风
Prevnar 13
pneumococcal 13-valent conjugate vaccine
Wyeth
A vaccine to prevent Streptococcus pneumoniae-related infections in children 6 weeks through 5 years.
肺炎球菌13价结合疫苗
Prolia
denosumab
破骨细胞抑制因子
Amgen鸟鸣涧
A RANK ligand inhibitor for treatment of postmenopausal osteoporosis.
有效降低患者骨质疏松症的风险
Provenge
sipuleucel-T
Dendreon
Autologous cellular immunotherapy for treatment of advanced prostate cancer.
前列腺癌疫苗
Teflaro
ceftaroline
CAS number400827-46-5
Forest Labs
An IV cephalosporin antibiotic for pneumonia and skin infections (including MRSA).
治疗肺炎的新抗菌药
Victoza
liraglutide
利拉鲁肽
Novo Nordisk
A GLP-1 agonist to improve gluco control in type 2 diabetes.
VPRIV
velaglucera alfa
治疗戈谢病
Shire
An enzyme replacement therapy for type 1 Gaucher dia.
治疗戈谢病
Xeomin
incobotulinumtoxinA
Merz Pharms.
An acetylcholine relea inhibitor and neuromuscular blocking agent for cervical dystonia and blepharospasm.
治疗颈部肌张力障碍和睑痉挛
Xgeva
denosumab
狄诺塞麦
Amgen
More concentrated formulation of Prolia to prevent fracture/pain associated with bone metastas.
用于预防实体瘤骨转移患者的骨骼相关事件
Xiaflex
collagena clostridium histolyticum
Auxilium Pharm.
A proteolytic enzyme for treatment of Dupuytren's contracture (a progressive hand dia which affects connective tissue in the palm of the hand).
用于治疗掌腱膜挛缩症
Zortress
everolimus
依维莫司
CAS number159351-69-6
Novartis
An immunosuppressant for prevention of organ rejection (kidney transplant).
用于治疗肾移植排异反应
Drug Withdrawals – 2010
Brand/Generic
 Company
 Description
Darvocet, Darvon, etc.
propoxyphene
Xanodyne
Withdrawn from the market due to risk of rious/fatal heart rhythm abnormalities.
Meridia
sibutramine
Abbott
Withdrawn from the market due to risk of rious cardiovascular events.
Mylotarg
gemtuzumab ozogamicin
Pfizer运动类的英语单词
Withdrawn from the market due to safety concerns and lack of clinical benefit.
Octagam
immune globulin
Octapharma USA
Withdrawn from market due to risk of thromboembolic events.
十分感谢
New Molecular Entities/Significant Biologicals - 2011
Brand/Generic
结构
Company
Description
DaTscan
ioflupane I 123
CAS number155797-99-2
GE Healthcare
Diagnostic imaging agent to evaluate patients with suspected Parkinsonian syndromes.
用于帕金森综合征的鉴别诊断
Natroba
spinosad
ParaPRO/Pernix
Topical pediculicide for treatment of head lice.
用于儿童和成人的头虱治疗
Viibryd
清炖羊肉放什么调料vilazodone.
维拉左酮
Trovis Pharm
An SSRI/rotonin receptor partial agonist for depression.

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