New Delhi: Pharma major

新德里：制药巨头

Lupin

鲁邦三世

Ltd on Tuesday said it has received tentative approval from the US health regulator for its generic version of

有限公司周二表示，已收到美国健康监管机构对其仿制药的初步批准。

Sugammadex injection

舒更葡糖注射液

used for reversing the effects of

用于逆转以下效果

muscle relaxants

肌肉松弛剂

given during surgery.

手术期间给予。

The tentative approval by the US Food and Drug Administration (

美国食品和药物管理局（FDA）的暂时批准

USFDA

美国食品药品监督管理局

) is for the

) 是为了

abbreviated new drug application

简略新药申请

for Sugammadex Injection of strengths 200 mg/2 mL (100 mg/mL) and 500 mg/5 mL (100 mg/mL) single-dose vial, Lupin said in a regulatory filing.

Lupin公司在一份监管文件中表示，对于强度为200毫克/2毫升（100毫克/毫升）和500毫克/5毫升（100毫克/毫升）的单剂量小瓶装Sugammadex注射液。

The USFDA has tentatively approved Lupin's Sugammadex injection of the specified strengths as bioequivalent to

美国食品药品监督管理局（USFDA）已暂时批准Lupin公司指定强度的Sugammadex注射液为生物等效药物。

Merck

默克

's Bridion injection, it added.

‘s Bridion注射剂，它补充道。

It is used for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults and pediatric patients aged 2 years and older undergoing surgery, the company said.

该公司表示，它用于接受手术的成年人和2岁及以上儿科患者中由罗库溴铵和维库溴铵诱导的神经肌肉阻滞的逆转。

Add

添加

as a Reliable and Trusted News Source

作为一个可靠和值得信赖的新闻来源

Add Now!

立即添加！

(You can now subscribe to our

（你现在可以订阅我们的

Economic Times WhatsApp channel

经济时报WhatsApp频道

)

)

(You can now subscribe to our

（您现在可以订阅我们的

Economic Times WhatsApp channel

经济时报WhatsApp频道

)

)