In February 2007, Advancis received a “refusal to file” letter from the FDA for its once-daily Amoxicillin PULSYS new drug application.
In its letter, the FDA indicated that Advancis' application was not sufficiently complete in that it did not include a proposed commercial batch record or a detailed commercial process description with process parameters and in-process controls.
Advancis believes it will be in a position to resubmit its new drug application in March 2007.
Should the FDA accept the application for filing, the company expects to receive a Prescription Drug User Fee Act action date about January 2008. If approved in January 2008, Advancis anticipates commercial launch of Amoxicillin PULSYS in late February 2008.