Mylan receives final FDA approval for ANDAs for Heparin Sodium Injection USP
Mylan announced it has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Applications for Heparin Sodium Injection USP, 1,000 USP/mL, 5,000 USP/mL, 10,000 USP/mL, and 20,000 USP/mL, all of which are packaged in multi-dose vials. Heparin is a complex injectable used as an anticoagulant in blood transfusions, extracorporeal circulation and dialysis procedures to prevent and treat various types of blood clots and to treat atrial fibrillation with embolization. Mylan's president Rajiv Malik commented, "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. Our investments over the last decade in our scientific and manufacturing capabilities, particularly in the injectables space, continue to pay off as we create a leading portfolio and a robust pipeline of complex products that differentiate us amongst our peers."