FDAnews
www.fdanews.com/articles/84565-inhibitex-moves-forward-with-bla-for-veronate

INHIBITEX MOVES FORWARD WITH BLA FOR VERONATE

February 14, 2006

Inhibitex has initiated the rolling submission of its biologics license application (BLA) with the FDA for the use of Veronate to prevent hospital-associated infections in infants weighing between 500 g and 1,250 g at birth.

The rolling submission is an FDA provision, available to drug candidates that have received Fast Track designation, which allows for completed sections of a BLA to be submitted on an ongoing basis.