Barr Pharmaceuticals, Inc. has announced that the U.S. Food and Drug Administration (FDA) has accepted for review Duramed Pharmaceuticals, Inc.'s Adenovirus Types 4 and 7 Live Oral Vaccines Biologics License Application (BLA).
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 Prescription Drug User Fee Action (PDUFA) date for the Adenovirus BLA is July 31, 2009.
"We are very pleased to have our first BLA accepted for filing by the FDA, and believe that we have achieved a significant step in building our biologics program," said Bruce L. Downey, Barr's Chairman and Chief Executive Officer. "Working together with Department of Defense (DOD) over the past six years we have made significant progress in meeting a critical unmet medical need for our Armed Forces. DOD's efforts to efficiently execute the clinical trial have enabled us to achieve this clinical milestone."