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.