The FDA has determined the Ranbaxy formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Cefzil tablets of Bristol-Myers Squibb. According to Ranbaxy, total annual market sales for cefprozil tablets were $76.6 million.
Cefprozil tablets are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in certain conditions, including tonsillitis, sinusitis, bronchitis and skin 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,” according to Jim Meehan, vice president of Sales and Marketing for Ranbaxy, USA.
Ranbaxy plans to bring this product to the market in early 2007 during the height of the respiratory season.