March 25, 2009
NDA to be submitted for VIAject for the treatment of diabetesBiodel announced its plan to submit a New Drug Application (NDA) to the 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.
For more information call (203) 796-5000 or visit www.biodel.com.