Biodel seeks FDA marketing approval for VIAject

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Mar 1 2010

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Biodel Inc. (Nasdaq: BIOD) announced today that the U.S. Food and Drug Administration has accepted for review the company’s new drug application (NDA) seeking approval to market VIAject® for the treatment of diabetes. VIAject® 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. It 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. Biodel submitted its marketing application to the FDA on December 30, 2009 and expects the Prescription Drug User Fee Act (PDUFA) action date for this NDA to be October 30, 2010.

SOURCE Biodel Inc.

Posted in: Medical Condition News | Pharmaceutical News

Tags: Blood, Diabetes, Endocrinology, Food, Insulin, New Drug Application, Prescription Drug, Type 1 Diabetes

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