Published on March 1, 2010 at 7:41 AM
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.