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Lupin获得美国FDA对多发性硬化症药物的批准

Lupin gets USFDA nod for multiple sclerosis drug

economictimes.indiatimes 等信源发布 2025-12-05 17:42

可切换为仅中文


New Delhi: Drug maker

新德里:制药商

Lupin

鲁邦三世

on Friday said it has received approval from the US health regulator to market a

周五表示,已获得美国健康监管机构的批准,可以销售一种

generic drug

通用药物

for the treatment of multiple sclerosis.

用于治疗多发性硬化症。

The company has received tentative approval from the US Food and Drug Administration (

公司已获得美国食品和药物管理局 (FDA) 的初步批准。

USFDA

美国食品药品监督管理局

) for its abbreviated new drug application for

) 因其简略新药申请而闻名

Siponimod Tablets

西波尼莫德片

in strengths of 0.25 mg, 1 mg and 2 mg, the Mumbai-based drugmaker said in a statement.

印度孟买制药商在一份声明中表示,药品规格有0.25毫克、1毫克和2毫克。

The new product would be manufactured at the company's Pithampur-based manufacturing facility.

新产品的生产将在该公司位于皮塔姆普尔的制造工厂进行。

Siponimod Tablets, 0.25 mg, 1 mg and 2 mg are bioequivalent to Mayzent tablets of

西波尼莫德片剂,0.25毫克、1毫克和2毫克与Mayzent片剂生物等效。

Novartis

诺华

Pharmaceuticals Corporation, and indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease, in adults.

制药公司,适用于治疗成人多发性硬化症(MS)的复发形式,包括临床孤立综合征、复发缓解型疾病和活动性继发进展型疾病。

As per the IQVIA MAT October 2025 data, Siponimod tablets had estimated annual sales of USD 195 million in the US.

根据IQVIA MAT 2025年10月的数据,Siponimod片剂在美国的年销售额估计为1.95亿美元。

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Lupin

鲁邦三世

were trading 0.42 per cent up at Rs 2,100.80 apiece on the BSE.

在BSE上,每股交易价格上涨了0.42%,达到2,100.80卢比。

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