Par Pharmaceutical Companies Inc has received final approval from the US Food and Drug Administration for its abbreviated new drug application (ANDA) for cefprozil tablets.
Cefprozil is the generic version of Bristol-Myers Squibb Company's broad-spectrum cephalosporin antibiotic Cefzil. Annual US sales of Cefzil tablets exceed $100 million, according to IMS Health.
Par will begin shipping the product immediately. Cefprozil tablets will be available in 250 mg and 500 mg strengths, claims a company release.
Par Pharmaceutical Companies Inc. develops, manufactures and markets generic drugs and innovative branded pharmaceuticals for specialty markets.