Ranbaxy's 'Cefprozil' gets US FDA approval

Mumbai: Ranbaxy Laboratories Ltd has received approval from the US Food and Drug Administration (FDA) to manufacture and market Cefprozil oral suspension. FDA's generic drugs office has found that the company's formulation, a bioequivalent of Bristol Mayer Squib's listed drug Cefzil oral suspension, has the same therapeutic effect as that of the reference drug.

Ranbaxy said total annual sales for Cefprozil were $93 million during the year ended March 2006.

Cefprozil suspension is useful for treatment of patients with mild to moderate infections of 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, Madhya Pradesh. Our plans are to bring this product to the market immediately," according to Jim Meehan, vice president of sales and marketing for Ranbaxy Pharmaceuticals Inc (RPI) in the US.

RPI, based in Jacksonville, Florida, is a wholly-owned subsidiary of Ranbaxy Laboratories, India's largest pharmaceutical company. RPI is engaged in the sale and distribution of generic and branded prescription products in the US.