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FDA Approves Apidra(R) SoloSTAR(R) - a Prefilled Disposable Insulin Pen
Date:2/26/2009

- Apidra(R) SoloSTAR(R) is a Convenient Insulin Delivery Device to Help Patients with Diabetes Improve Glycemic Control

BRIDGEWATER, N.J., Feb. 26 /PRNewswire-FirstCall/ -- Sanofi-aventis announced today that the U.S. Food and Drug Administration (FDA) approved Apidra(R) SoloSTAR(R) (insulin glulisine [rDNA origin] injection), a prefilled disposable pen containing rapid-acting insulin analog Apidra(R), which is indicated to improve glycemic control in adults and children (4 years and older) with type 1 diabetes or adults with type 2 diabetes.

The approval of Apidra(R) SoloSTAR(R) follows the approval and launch of Lantus(R) SoloSTAR(R) (insulin glargine [rDNA origin] injection) in 2007. People living with diabetes who use both Lantus(R) and Apidra(R) to help manage their blood sugar will now have two pen delivery devices to make administration of their insulins convenient. Basal-prandial insulin regimens that combine once-daily Lantus(R) as a basal insulin analog with rapid-acting Apidra(R) at mealtime can closely mimic normal physiologic insulin secretion.

"Patients with diabetes have to contend with the challenges of carbohydrate counting, regular blood sugar monitoring and careful administration of their insulin," said Angela Moskow, Vice President, Metabolism Marketing, sanofi-aventis, U.S. "Apidra(R) SoloSTAR(R) represents another innovation introduced by sanofi-aventis that offers patients a convenient option for administering their Apidra(R)."

The Apidra(R) SoloSTAR(R) and Lantus(R) SoloSTAR(R) pens are the result of over four years of intensive development, and were designed in dialogue with patients, nurses and doctors to meet their needs and the high standards of the industry.

Apidra(R) SoloSTAR(R) and Lantus(R) SoloSTAR(R) are designed with completely different colors to help patients differentiate between the two pens, which are intended for use with two very dif
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SOURCE sanofi-aventis
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