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FDA OKs new route of giving Sanofi drug

BRIDGEWATER, N.J., June 15 (UPI) -- Sanofi-aventis Friday said the U.S. Food and Drug Administration approved its rapid-acting insulin, Apidra, for intravenous administration.

The additional route of administration may benefit hospitalized diabetes patients who require intravenous insulin therapy.

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"Many of the patients I treat in the inpatient setting have diabetes and require intravenous insulin," Christopher Newton, assistant professor of medicine in East Carolina University's division of endocrinology, said in a statement issued by Sanofi.

"The new indication for Apidra is an important development, as it gives clinicians a new option to help achieve and maintain blood glucose control in these patients in this setting," Newton added.

The FDA's decision was based on a crossover study involving 16 healthy male subjects who received an intravenous infusion of Apidra or regular human insulin. Both treatments produced equivalent glucose disposal at steady state.

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