Biodel Inc. to Submit New Drug Application for VIAject(R) to FDA

DANBURY, Conn.--(BUSINESS WIRE)--Biodel Inc. (Nasdaq: BIOD) announced today its plan to submit a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) in the second half of this year for approval to market VIAject® for the treatment of diabetes. VIAject® is Biodel’s investigational ultra-rapid-acting injectable human insulin intended for meal-time use by people with Type 1 and Type 2 diabetes. The NDA will be based upon results from multiple pharmacokinetic and pharmacodynamic studies as well as two completed Phase 3 studies of VIAject® in patients with Type 1 and Type 2 diabetes.

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