RANBAXY'S GENERIC CEFPROZIL TABLETS APPROVED

Ranbaxy Laboratories has received approval from the FDA to manufacture and market cefprozil tablets 250 and 500 mg. The FDA's Office of Generic Drugs has determined the Ranbaxy formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug, Bristol Myers Squibb's Cefzil.

Total annual sales for all cefprozil tablets were $76.6 million for the year ending in September, according to IMS data.

Cefprozil is an antibiotic indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in certain conditions, including: pharyngitis/tonsillitis, acute sinusitis, secondary bacterial infection of acute bronchitis and acute bacterial exacerbation of chronic bronchitis, and uncomplicated skin and skin-structure infections.

Earlier this year Ranbaxy won approval for generic cefprozil for oral suspension, 125 mg/5 mL and 250 mg/5 mL.