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2010及2011年FDA批准新药(我院协助购买)

ID号:512  发布日期: 2012-04-27    截止日期: 不限  地区:全国 浏览次数:164

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 severe 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 varicose 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 synthase 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

CAS number126784-99-4

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 relapses and delay disability progression in certain patients with multiple sclerosis.

多发性硬化症治疗药

Glassia
alpha1-proteinase inhibitor

α1-人蛋白酶抑制剂

 

Kamada

Replacement therapy for patients with emphysema due to deficiency of alpha1-proteinase 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.

用于前列腺癌

Krystexxa
pegloticase

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
alglucosidase alfa

阿葡糖苷酶α

CAS number420794-05-0

Genzyme

An enzyme needed for muscle function with late-onset Pompe disease.

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 disease caused by Neisseria meningitidis serogroups 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

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

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 glucose control in type 2 diabetes.

VPRIV
velaglucerase alfa

治疗戈谢病

 

Shire

An enzyme replacement therapy for type 1 Gaucher disease.

治疗戈谢病

Xeomin
incobotulinumtoxinA

 

Merz Pharms.

An acetylcholine release 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 metastases.

用于预防实体瘤骨转移患者的骨骼相关事件

Xiaflex
collagenase clostridium histolyticum

 

Auxilium Pharm.

A proteolytic enzyme for treatment of Dupuytren's contracture (a progressive hand disease 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 serious/fatal heart rhythm abnormalities.

Meridia
sibutramine

Abbott

Withdrawn from the market due to risk of serious cardiovascular events.

Mylotarg
gemtuzumab ozogamicin

Pfizer

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.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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
vilazodone
.

维拉左酮

 

Trovis Pharm

An SSRI/serotonin receptor partial agonist for depression.

 

 

 

 

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