FDA gives nod to Valeritas insulin delievery system

Twitter icon
Facebook icon
LinkedIn icon
e-mail icon
Google icon

The FDA has granted Valeritas 510(k) clearance for its V-Go disposable insulin delivery system to be used in conjunction with the delivery of NovoLog, Novo Nordisk’s fast-acting insulin, a basal-bolus insulin therapy for type 2 diabetics.

The V-Go disposable insulin delivery system is available to deliver 20, 30 or 40 units of insulin in one 24-hour period (0.83 U/hr, 1.25 U/hr or 1.67 U/hr, respectively), according to the Bridgewater, N.J.-based Valeritas. The device can also deliver an on-demand bolus dosing in two unit increments—up to 36 units in a 24-hour time period.

The delivery system weighs an estimated one ounce when filled with insulin and measures 2.3 x 1.3 x 0.5 inches. The system is worn under patient’s clothes.

The system was approved in December 2010 to be used with Eli Lilly’s HumaLog.