Biodel (BIOD) Plans to Submit NDA for VIAject(R) to FDA
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Biodel Inc. (Nasdaq: BIOD) announced today its plan to submit a new drug application to the U.S. FDA in the second half of this year for approval to market VIAject(R) for the treatment of diabetes. VIAject(R) 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(R) in patients with Type 1 and Type 2 diabetes.
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