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Alembic Pharma获得美国食品药品监督管理局对仿制药的批准

Alembic Pharma gets USFDA nod for generic product

economictimes.indiatimes 等信源发布 2024-09-05 20:26

可切换为仅中文


Alembic Pharmaceuticals on Thursday said it has received approval from the US health regulator to market a generic drug used to treat infections caused by worms. The company has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Albendazole Tablets USP (200 mg), the drug maker said in a statement.

Alembic Pharmaceuticals周四表示,已获得美国卫生监管机构的批准,可以销售一种用于治疗蠕虫感染的仿制药。该制药商在一份声明中表示,该公司已获得美国食品和药物管理局(USFDA)批准其缩写新药申请(ANDA)阿苯达唑片剂USP(200 mg)。

The approved ANDA is therapeutically equivalent to Impax Laboratories, Inc.'s LAlbenza tablets, it added. Albendazole tablets are indicated for the treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm, Taenia solium. It is also indicated for the treatment of cystic hydatid disease of the liver, lung, and peritoneum, caused by the larval form of the dog tapeworm, Echinococcus granulosus.

它补充说,经批准的ANDA在治疗上等同于Impax Laboratories,Inc.的LAlbenza片剂。阿苯达唑片用于治疗由猪绦虫幼虫形式引起的活动性病变引起的实质性神经囊虫病。它还可用于治疗由狗绦虫细粒棘球绦虫幼虫引起的肝,肺和腹膜囊性包虫病。

Alembic Pharma shares on Thursday ended 2.79 per cent higher at Rs 1,145.80 apiece on the BSE.(You can now subscribe to our Economic Times WhatsApp channel)(You can now subscribe to our Economic Times WhatsApp channel).

Alembic Pharma股价周四在BSE上涨2.79%,收于1145.80卢比(您现在可以订阅我们的经济时报WhatsApp频道)(您现在可以订阅我们的经济时报WhatsApp频道)。