The US Food and Drug Administration (FDA) has approved use of Mylan NV’s heparin products.
This includes Heparin Sodium Injection at 1000 USP/mL, 5000 USP/mL, 10,000 USP/mL, and 20,000 USP/mL, all of which are packaged in multi-dose vials.
These products should be available in the coming weeks, according to Rajiv Malik, the president of Mylan.
Mylan’s heparin products are approved for the same uses as other heparin products approved in the US.
This includes as prophylaxis and treatment for venous thrombosis and its extension, pulmonary embolism, and peripheral arterial embolism.
The heparin products can also be used to treat atrial fibrillation with embolization, prevent clotting in arterial and cardiac surgery, and diagnose/treat acute and chronic consumptive coagulopathies (disseminated intravascular coagulation).
Low-dose heparin can be used to prevent post-operative deep vein thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease.
Heparin can also be used as an anticoagulant in blood transfusions, extracorporeal circulation, and dialysis procedures, as well as in blood samples for laboratory purposes.
“We are very proud of today’s FDA approval of Heparin Sodium Injection, as this approval adds yet another highly complex and difficult-to-manufacture product to our portfolio,” Malik said.
“We expect to make our heparin products available to US hospitals in the coming weeks, further supporting our institutional customers in meeting the needs of their patients who depend on high-quality anticoagulants.”