Alembic Pharmaceuticals on Tuesday said it has received approval from the US health regulator to market a generic product indicated for prophylaxis of deep vein thrombosis. The company has received approval from the US Food and Drug Administration (USFDA) to market Dabigatran Etexilate Capsules (110 mg), the drug firm said in a regulatory filing.

Alembic Pharmaceuticals周二表示，已获得美国卫生监管机构的批准，可以销售一种用于预防深静脉血栓形成的仿制药。该制药公司在一份监管文件中表示，该公司已获得美国食品和药物管理局（USFDA）的批准，可以销售达比加群酯胶囊（110毫克）。

Dabigatran Etexilate Capsules are indicated for prophylaxis of deep vein thrombosis and pulmonary embolism following hip replacement surgery. The approved product is therapeutically equivalent to Boehringer Ingelheim Pharmaceuticals Inc's Pradaxa Capsules (110 mg). The company said it now has a cumulative total of 211 ANDA (abbreviated new drug application) approvals from the USFDA.

达比加群酯胶囊用于预防髋关节置换术后深静脉血栓形成和肺栓塞。经批准的产品在治疗上等同于勃林格殷格翰制药公司的Pradaxa胶囊（110毫克）。该公司表示，目前已获得美国食品和药物管理局（USFDA）累计211份ANDA（缩写新药申请）批准。