In Brief: Schering's Cedax
Executive Summary
Schering's Cedax: Ceftibuten dihydrate 400 mg capsules and powder for oral suspension (90 mg/5 mL and 180 mg/5 mL) receive "approvable" letter from FDA Sept. 7. The cephalosporin antibiotic for upper and lower respiratory tract and urinary tract infections was approvable once before, on Dec. 29, 1994...