阿拉宾度得到USFDA点头乙型肝炎药物

StephenW

Aurobindo gets USFDA nod for hepatitis B drug
Thursday, 27 August 2015 - 1:03pm IST | Place: New Delhi | Agency: PTI

According to IMS data, the product has an estimated market size of $294 million for the 12 months ending June 2015.

  

Aurobindo Pharma has received approval from the US health regulator to market generic Entecavir tablets, used to treat hepatitis B, in the American market.

The company has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Entecavir tablets in strengths of 0.5mg and 1mg, Aurobindo Pharma said in a statement.

The Hyderabad-based firm's approved abbreviated new drug application (ANDA) is therapeutically equivalent to Bristol-Myers Squibb's Baraclude tablets.

Entecavir tablets are indicated for treatment of chronic hepatitis B virus infection of the liver.

According to IMS data, the product has an estimated market size of $294 million for the 12 months ending June 2015.

"This is the 44th ANDA to be approved out of Unit VII formulation facility in Hyderabad for manufacturing oral non-antibiotic products," the company said.

The company has now a total of 209 ANDA approvals from the USFDA.

Aurobindo Pharma shares were trading at Rs 744 apiece on BSE, up 2.90% from previous close.  MSS ABK

阿拉宾度得到USFDA点头乙型肝炎药物
周四，2015年8月27日 - 下午1点03 IST |地点：新德里|机构：PTI

根据IMS的数据，该产品具有的$ 294个亿，估计市场规模在截至2015年6月的12个月。

  

阿拉宾度制药公司已经获得批准，美国医疗监管机构向市场推出通用的恩替卡韦片，用于治疗乙肝，在美国市场。

该公司已收到美国食品和药物管理局（USFDA）最终批准生产和销售恩替卡韦片在0.5毫克和1毫克的优势，阿拉宾度制药公司在一份声明中说。

海得拉巴的一家公司批准的简化新药申请（ANDA）是治疗等效于施贵宝公司的博路定片。

恩替卡韦片的适应症是治疗慢性乙肝病毒感染的肝脏。

根据IMS的数据，该产品具有的$ 294个亿，估计市场规模在截至2015年6月的12个月。

“这是第44届ANDA被批准了单位制定第七设施在海得拉巴制造口服非抗生素类产品，”该公司表示。

公司目前共拥有来自美国食品药品管理局209 ANDA批准。

阿拉宾度制药公司股价现744卢比每人疯牛病交易，同比增长2.90％，从之前的接近。 MSS ABK

老折腾

这个翻译，简直疯牛病