Bivalirudin for Injection Receives U.S. FDA Final Approval

2020-04-28 09:49
On 23 October 2019, Hainan Shuangcheng Pharmaceuticals Co. Ltd (the “company”) received the notification from the U.S. Food and Drug Administration (FDA) that the ANDA (abbreviated new drug application) of Bivalirudin for Injection submitted has been approved. The U.S. FDA’s final approval of the ANDA of Bivalirudin for Injection indicates the product developed by the company has reached the international level in terms of safety and effectiveness. By challenging the patent of the RLD (reference listed drug), the company advances the entering of the product in the U.S. market.
Bivalirudin is a reversible specific thrombin inhibitor for injection and is approved in the U.S. for use as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI).
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