Ranbaxy Laboratories Limited (RLL) has received US FDA approval to manufacture and market Cefprozil tablets USP, 250 mg and 500 mg. The generic drugs office of US FDA has found the company's formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Cefzil tablets, 250 mg and 500 mg, respectively, of Bristol Myers Squibb Company Pharmaceutical Research Institute. Cefzil is the registered trademark of Bristol Myers Squibb Company Pharmaceutical Research Institute Total annual market sales for Cefprozil tablets were $76.6 million as per the IMS - MAT studies September 2006.
Cefprozil tablets are used in the treatment of mild to moderate infections by susceptible strains of the designated micro organisms in various conditions including pharyngitis/tonsillitis, otitis media, acute sinusitis, secondary bacterial infection of acute bronchitis, acute bacterial exacerbation of chronic bronchitis, uncomplicated skin and skin-structure infections.
"Ranbaxy is pleased to be granted approval for Cefprozil tablets which represents yet another addition to our ever-growing product portfolio of anti-infectives that will be available as an affordable generic alternative to the brand equivalent. This formulation will be produced in our cGMP compliant, cephalosporin dedicated facility located in Dewas, India. Our plans are to bring this product to the market in early 2007 during the height of the respiratory season," maintained Jim Meehan, Vice President of Sales and Marketing for RPI, USA.