BEIJING, June 4 (Xinhua) -- Hainan Shuangcheng Pharmaceuticals Co., Ltd (002693.SZ) announced on Monday that its abbreviated new drug application (ANDA) for injection of bivalirudin, which was filed with the Food and Drug Administration of the U.S. (FDA) on December 27, 2016, has been tentatively approved.
Bivalirudin is a direct inhibitor of thrombin and is used for anticoagulation.
The original drug of the bivalirudin for injection was developed by The Medicines Company and approved by the FDA in the United States on December 15, 2000. At present, the U.S. original drug product has not yet been available in China.
The company's bivalirudin for injection is China's first generic drug of this type approved in the United States. The company’s application for the product listing in China is still in the review stage, said the Shenzhen-listed company. (Edited by Hu Pingchao, hupingchao@xinhua.org)
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