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 completely latex-free and features the Company's proprietary PreventIV Measures™ packaging and labeling, which aids users in distinguishing between the nine presentations. Sagent's packaging and labeling features for heparin include the use of a unique color for each total strength, easy to read drug name, concentration and fill volume, and cartons printed on all sides. PreventIV Measures™ is Sagent's comprehensive, user-driven and patient-centered approach to product labeling and packaging that considers everyone handling medication along the way in order to help prevent medication errors.
"The pace of hospital care is faster than it has ever been, requiring increased vigilance to reduce treatment errors," said Elaine Levy, system director, Pharmacy Sharp HealthCare in San Diego, CA. "Sagent's PreventIV Measures™ approach to packaging and labeling design makes it easier to differentiate drugs from others in the same class, even when the medications look or sound alike. Further, it makes it easier to distinguish between doses, which is especially important when working with medications like heparin that have a number of concentrations and sizes. I believe that features such as those incorporated into Sagent's products can help reduce those errors caused by selecting the incorrect medication for a patient."
About Heparin Sodium Injection, USP
Heparin is indicated for anticoagulant therapy in prophylaxis and treatment of venous thrombosis and its extension; low-dose regimen for prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease (see DOSAGE AND ADMINISTRATION); prophylaxis and treatment of pulmonary embolism; atrial fibrillation with embolization; diagnosis and treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation); prevention of clotting in arterial and cardiac surgery; and prophylaxis and treatment of peripheral arterial embolism.
The package insert, which is available at www.SagentPharma.com, contains detailed information about the indication, complete side effect profile, boxed warnings and prescribing information.
About PreventIV Measures™
PreventIV Measures™ is Sagent's comprehensive, user-driven and patient-centered approach to product labeling and packaging that is designed to help prevent medication errors. It incorporates unique label and carton designs, cap and label colors, bar coding and other features that are designed to make it easier to differentiate drugs and identify the correct dose.
About Sagent Pharmaceuticals, Inc.
Sagent Pharmaceuticals, founded in 2006, is a privately held specialty pharmaceutical company focused on developing, manufacturing, sourcing and marketing pharmaceutical products, with a specific emphasis on injectable products. Sagent has created a unique, global network of resources, comprised of rapid development capabilities, sophisticated manufacturing and innovative drug-delivery technologies, quickly yielding an extensive portfolio of pharmaceutical products that fulfills the evolving needs of patients.
To Discover Injectables Excellence™ and learn more about Sagent, please visit www.SagentPharma.com.
SOURCE Sagent Pharmaceuticals, Inc.