Biodel, Inc.
Biodel Submits VIAject(R) New Drug Application to FDA for Treatment of Diabetes
Published in Medical Letter on the CDC and FDA, January 17th, 2010
Biodel, Inc. (Nasdaq: BIOD) announced that it has submitted a new drug application (NDA) to the U.S. Food and Drug Administration for clearance to market VIAject® as a treatment for 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 is Biodel's most advanced product candidate and has been tested in more than 884 patients who participated in Phase 1, 2 and 3 clinical trials of the drug in the United States, Germany and India. Biodel is seeking approval to market VIAject® in the United States as a 100 IU/cc, pH7 (neutral) injectable...
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