On December 23, Glonghui reported that Brightgene Bio-Medical Technology Co.,Ltd. (688166.SH) announced it has received notification from the FDA that its Abbreviated New Drug Application (ANDA) for Fondaparinux Sodium Injection has been officially approved.
Fondaparinux is a fully synthetic anticoagulant indicated for the prevention of venous thromboembolism in patients undergoing major orthopedic surgeries such as hip fracture, major knee surgery, or hip replacement. It is used for the treatment of unstable angina or non-ST elevation myocardial infarction (UA/NSTEMI) patients undergoing emergency (<120 minutes) invasive treatment (PCI) and for patients with ST elevation myocardial infarction who are initially not receiving other forms of reperfusion therapy or thrombolysis.