Barr's adenovirus vacc BLA accepted by FDA

US specialty drugmaker Barr Pharmaceuticals says that the Food and Drug Administration has accepted for review subsidiary Duramed Pharmaceuticals' adenovirus types 4 and 7 live oral vaccines Biologics License Application. These oral vaccines represent Barr's first in-house biologics development initiative and demonstrate the company's ability to develop, manufacture and conduct clinical trials for biologic products, the firm notes. The Prescription Drug User Fee Action date for the adenovirus BLA is July 31, 2009.