BD Receives FDA Clearance for New Syringe Designed for the Administration of Humulin® R U-500 Insulin
FRANKLIN LAKES, N.J., AUGUST 15, 2016 – BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced it has received U.S. Food and Drug Administration (FDA) clearance for its new syringe for patients using Humulin R U-500 insulin vials. Humulin R U-500 insulin is indicated for patients with diabetes requiring more than 200 units of insulin per day. Compared to syringes made for U-100 insulin, the new BD U-500 Insulin Syringe is designed to make it easier for patients and health care providers to draw the correct dose of U-500 insulin by reducing steps that can result in dosing errors.
"BD is committed to advancing the world of health through innovative products which promote patient safety. FDA clearance of the BD U-500 Insulin Syringe is a positive step forward for both health care providers and patients who previously relied on manually converting U-500 insulin doses to the appropriate dose or volume, when using a U-100 insulin syringe," said Ken Miller, worldwide president of Diabetes Care for BD. "With the new syringe, dose conversion is no longer needed, which helps reduce potential medication errors by both patients and health care providers."
The BD U-500 Insulin Syringe is the first and only insulin syringe developed for patients taking Humulin R U-500 insulin. The BD U-500 Insulin Syringe features a 6mm x 31G syringe needle, the shortest insulin syringe needle available today, which is designed to deliver insulin injections into the subcutaneous tissue while minimizing the risk of intramuscular injection. The BD U-500 Insulin Syringe also has clearly marked dosage labeling designed to distinguish between other syringes, to help prevent confusion and incorrect dosing. The new insulin syringe is a 0.5mL syringe with clear, bold U-500 scale markings in 5 unit increments and allows for dosing up to 250 units. The syringe package and components are color coded to align with the Humulin-R U-500 insulin green and aqua color scheme.
The BD U-500 Insulin Syringe for use with Humulin R U-500 insulin vials will be available by prescription only. Commercial availability is planned for November 2016.
BD is a global medical technology company that is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. BD leads in patient and health care worker safety and the technologies that enable medical research and clinical laboratories. The company provides innovative solutions that help advance cellular studies and genomics, enhance the diagnosis of infectious disease and cancer, improve medication management, promote infection prevention, equip surgical and interventional procedures, optimize respiratory care and support the management of diabetes. The company partners with organizations around the world to address some of the most challenging global health issues. BD has more than 45,000 associates across 50 countries who work in close collaboration with customers and partners to help enhance outcomes, lower health care delivery costs, increase efficiencies, improve health care safety and expand access to health. For more information on BD, please visit bd.com.