FDA Approves Sagent Pharmaceuticals' Heparin Sodium Injection, USP
SCHAUMBURG, Ill., July 1 /PRNewswire/ -- Sagent Pharmaceuticals, Inc., a privately held specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved the Company's nine presentations of heparin sodium injection, USP. Heparin is a vital anticoagulant, preventing the formation of clots and extension of existing clots within the blood, routinely used in surgical and dialysis settings. According to IMS, 2009 U.S. sales of all forms of unfractionated heparin approximated $306 million. Sagent will launch the product immediately.
"Attaining FDA approval of Sagent's heparin vials is a major accomplishment for our company," said Jeffrey M. Yordon, chief executive officer, founder, and chairman of the board of Sagent. "Amidst the many challenges the nation's supply of heparin has recently faced, Sagent identified and readied a reliable source for heparin and successfully navigated the FDA approval process for each of our heparin presentations. We believe that our innovative approach to the packaging and labeling of our heparin provides us with a significant advantage in the market by better meeting the requirements of patients and customers, positioning us for a successful launch."
As with all of Sagent's products, heparin is com