FDA Accepts Biodel’s New Drug Application for Review

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Biodel Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s new drug application seeking approval to market VIAject(R) for the treatment of diabetes. VIAject(R) is Biodel’s proprietary formulation of recombinant human insulin that is designed to be absorbed into the blood faster than currently marketed rapid-acting insulin analogs.
The new drug has been tested in more than 875 patients who participated in Phase 1, 2 and 3 clinical trials of the drug in the United States, Germany and India.

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