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Saturday, December 11, 2010

Valeritas FDA 510(k) Clearance for the V-Go™ Disposable Insulin Delivery Device

Valeritas, Inc.December 8, 2010 - V-Go provides Type 2 diabetic patients a simple option for basal-bolus insulin therapy - Valeritas, Inc., a medical technology company committed to the development and commercialization of innovative drug delivery solutions, announced that the US Food and Drug Administration has cleared the company's V-Go Disposable Insulin Delivery Device for the continuous subcutaneous delivery of insulin in preset basal rates and with on-demand bolus dosing for adult patients requiring insulin. V-Go devices will be available in a preset basal rate to deliver 20, 30 or 40 Units of insulin in one 24-hour period (0.83 U/hr, 1.25U/hr or 1.67U/hr respectively) and on-demand bolus dosing in 2 Unit increments (up to 36 Units per one 24-hour time period).

"The V-Go Disposable Insulin Delivery Device is the first fully disposable, non-electronic basal-bolus device that is specifically designed with the Type 2 population in mind," said Valeritas CEO Kristine Peterson. "We believe that the simple user features of the V-Go will allow more patients with diabetes to adhere to their insulin regimen, which ultimately may lead to better control." ... Valeritas' Press Release -