Teva receives US FDA approval for cefprozil tabs, cefprozil for oral suspension
Teva Pharmaceutical Industries Ltd. has received an approval from the US Food and Drug Administration the company’s ANDAs for cefprozil tablets USP, 250 mg and 500 mg and cefprozil for oral suspension USP, 125 mg/5 ml and 250 mg/5 ml. Shipment of these products is expected to commence upon expiry of brand exclusivity later this month.
Teva’s cefprozil tablets and cefprozil for oral suspension are the AB-rated generic equivalents of Bristol-Myers Squibb’s broad-spectrum cephalosporin antibiotic Cefzil, states a company release.
Annual sales Cefzil tablets and Cefzil for oral suspension are approximately $114 million and $116 million, respectively.
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies and among the largest generic pharmaceutical companies in the world. The company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients.