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Valeritas Receives FDA 510(k) Clearance for the V-Go™ Disposable Insulin Delivery Device for Use with NovoLog®
Date:3/1/2011

BRIDGEWATER, N.J., March 1, 2011 /PRNewswire/ -- Valeritas, Inc., a medical technology company committed to the development and commercialization of innovative drug delivery solutions, announced today that the U.S. Food and Drug Administration has cleared the company's V-Go Disposable Insulin Delivery Device for use with Novo Nordisk's NovoLog® for the continuous subcutaneous delivery of insulin in preset basal rates and with on-demand bolus dosing for adult patients requiring insulin.  In December 2010, Valeritas received FDA clearance for the V-Go's use with Eli Lilly's Humalog®.

"With the addition of NovoLog® to the V-Go label, we have demonstrated that the two most widely prescribed fast acting insulins in the United States can be used safely with the V-Go and thereby have increased healthcare professional and patient insulin options available for use with the V-Go Disposable Insulin Delivery Device," said Valeritas CEO Kristine Peterson.  

About the V-Go Disposable Insulin Delivery Device

The V-Go is the first simple, fully disposable device for the delivery of basal-bolus insulin therapy for adults with diabetes. The V-Go provides a continuous preset basal rate of insulin and allows for on-demand bolus dosing around mealtimes thereby providing an alternative to taking multiple daily insulin injections.  

The V-Go is engineered to simplify basal-bolus insulin therapy for the millions of people suffering from Type 2 diabetes. The V-Go is small, lightweight, and worn under the patients' clothing. It measures just 2.4 x 1.3 x 0.5 inches and weighs approximately 1 ounce when filled with insulin. Patients apply a new V-Go to the skin daily for one 24-hour period. The V-Go is not electronic, making it easy to operate and use.

The V-Go is filled with insulin using a very simple point-of-care filling accessory – the EZ Fill (which will be included with each monthly supply of
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SOURCE Valeritas, Inc.
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