Ranbaxy Laboratories has received approval from the US FDA to manufacture and market Cefprozil for oral suspension USP, 125 mg/5mL and 250 mg/5mL.
The US FDA has determined the company's formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Cefzil for oral suspension by Bristol Myers Squibb Company Pharmaceutical Research Institute. Total annual market sales for Cefprozil were $93 million, a company release stated.
Cefprozil suspension is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed: Pharyngitis/tonsillitis, Otitis Media, Acute Sinusitis, secondary bacterial infection of Acute Bronchitis and Acute Bacterial Exacerbation of Chronic Bronchitis and uncomplicated skin and skin-structure infections.
"Ranbaxy is pleased to market this product as an addition to our ever growing product portfolio of anti-infectives that will be available as an affordable generic to the brand. This formulation will be produced in our cGMP compliant, cephalosporin dedicated facility in Dewas, India. Our plans are to bring this product to the market immediately," according to Jim Meehan, vice president of sales and marketing for RPI, USA.