Advancis, which resubmitted the Pulsys application in March, said the FDA set a deadline of Jan. 23 for action on the drug.

Pulsys is a once-daily medication intended to offer a more convenient alternative to currently available penicillin and amoxicillin regimens, which may improve patient compliance.

Advancis said if Pulsys is approved by January, it could launch the product as early as the beginning of the 2008/2009 cough and cold season.

Amoxicillin prescriptions generated $640 million in sales in 2006.