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FDA Approves Prefilled Disposable Pen Containing Rapid-acting Insulin Analog

BRIDGEWATER, N.J., Feb. 26 /PRNewswire-FirstCall/ -- Sanofi-aventis announced today that the U.S. Food and Drug Administration (FDA) approved Apidra SoloSTAR (insulin glulisine [rDNA origin] injection), a prefilled disposable pen containing rapid-acting insulin analog Apidra , 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 SoloSTAR follows the approval and launch of Lantus SoloSTAR (insulin glargine [rDNA origin] injection) in 2007. People living with diabetes who use both Lantus and Apidra 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 as a basal insulin analog with rapid-acting Apidra 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 SoloSTAR represents another innovation introduced by sanofi-aventis that offers patients a convenient option for administering their Apidra ."

The Apidra SoloSTAR and Lantus SoloSTAR 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 SoloSTAR and Lantus SoloSTAR are designed with completely different colors to help patients differentiate between the two pens, which are intended for use with two very different types of insulins (rapid-acting vs. long-acting). The differentiation of the Apidra SoloSTAR and Lantus SoloSTAR was shown in a specific comparative study. Nevertheless, before using Apidra SoloSTAR or Lantus SoloSTAR , patients should carefully examine the labeling on the pen, to ensure they are using the correct one. Apidra SoloSTAR operates with a low injection force and two studies found that this delivery device required less injection force than the Novo Nordisk FlexPen and the Eli Lilly Humulin/Humalog pen.

Apidra SoloSTAR is expected to be available in pharmacies this year.

Source: Sanofi-aventis

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