Par Pharmaceutical Companies, Inc. recently announced that it had received final approval from the FDA for its Abbreviated New Drug Application for cefprozil for oral suspension. Cefprozil is the generic version of Bristol-Myers Squibb Company’s broad-spectrum cephalosporin antibiotic Cefzil®. Annual U.S. sales of Cefzil® for Oral Suspension exceed $100 million.
Par will begin shipping the product immediately. Cefprozil for oral suspension is available in strengths of 125 mg/5 mL and 250 mg/5 mL.