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New diabetes drug waiting for FDA approval

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By David Liu

Biodel Inc. (BIOD) was cited as saying that it has asked the Food and Drug Administration to approve its VIAject, a medication indicated for diabetes treatment.

VIAject is a type of insulin that can be absorbed into the blood faster than other insulin analogs now in the market.  People with diabetes need to carefully manage the glucose level in their blood.

A trial of more than 884 diabetes patients conducted in the U.S., Germany and India reportedly demonstrated the efficacy and safety that may be required for the FDA approval.

Chairman and Chief Executive Dr. Sol Steiner was quoted by the Wall Street Journal as saying "Patients receiving VIAject had faster reductions in blood glucose activity, reduced risks of hyperglycemia and hypoglycemia and less weight gain than patients who received recombinant human insulin."

VIAject will be sold in an injectable liquid in 10-milliter vials and 3-milliliter pen cartridges. 

Diabetes affects an estimated 20 million Americans.  The health condition can lead to some lethal medical problems including death and it costs billions of dollars in diagnosis and treatment.

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