Barr Pharmaceuticals announced Thursday that the FDA has accepted their application for the company's first two biologics, developed for the Department of Defense. The vaccine pills are designed to protect against two strains of the common cold virus--adenovirus types 4 and 7. Adenoviruses infections are most common in children and can cause common colds, as well as pneumonia, bronchitis and gastroenteritis.
"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 CEO. "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."
The FDA's is expected to make a decision by July 31, 2009, according to Barr's statement.
- see the Barr release