2010及其2012FDA批准新药.doc

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 number:1188-38-1
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***受体调节剂
CAS number:126784-99-4
Watson
A progesterone agonist/antagonist emergency contraceptive.
紧急避孕药
Gilenya
fingolimod
CAS number:162359-55-9
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