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阿拉宾度抗HIV仿制药Abacavir获FDA批准

来源:生物谷 2012-12-24 14:56

2012年12月24日讯 /生物谷BIOON/ --阿拉宾度(Aurobindo)抗HIV药物Abacavir片(300mg)获FDA批准,该药为ViiV Healthcare公司Ziagen片(300mg)的仿制药,作为抗逆转录病毒联合疗法的一部分,用于成人及儿童HIV感染的治疗。(生物谷bioon.com)

英文原文:

Aurobindo Pharma has won the final FDA approval to manufacture and market its generic anti-Human Immunodeficiency Virus (HIV) drug, Abacavir Tablets USP 300mg.

Abacavir, the generic version of ViiV Healthcare Company's Ziagen Tablets 300mg, is used to treat HIV infected adults and children as a part of antiretroviral (ARV) combination therapy.

The product that has been approved out of its Hyderabad Unit III formulations facility is ready for launch, according to the company.

Each Ziagen tablet contains abacavir sulfate equivalent to 300mg of abacavir as active ingredient in addition to inactive ingredients such as colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.

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