Ranbaxy Laboratories Ltd has received final approval from the US Food and Drug Administration (US FDA) to manufacture and market Clarithromycin for oral suspension, USP, 125 mg/5 mL and 250 mg/5 mL.

The company is the first company to have been granted a generic approval for the oral suspension form along with Clarithromycin tablets. The total annual market sales for Clarithromycin were $99.7 million with suspension sales totalling $25.3 mn (IMS MAT: June 2007).

"We are pleased to receive this FDA approval for Clarithromycin for oral suspension, an anti-infective agent that will add depth and breadth to our product line of anti-infectives that also includes Clarithromycin tablets. RPI will be in a position to offer both dosage forms for this molecule that will distinguish Ranbaxy in the market place. This approval further expands our product portfolio of affordable generic alternatives and will he shipped immediately to all classes of trade," according to Jim Meehan, vice president of sales and distribution for Ranbaxy Pharmaceuticals Inc. (RPI).

The office of generic drugs, US FDA, determined the Ranbaxy formulation to be bioequivalent and to have the same therapeutic effect as that of the reference listed drug Biaxin granules (Clarithromycin for Oral Suspension, USP), 125 mg/5 mL and 250 mg/5 mL of Abbott Laboratories.

Clarithromycin for oral suspension, USP, is indicated for the treatment of mild to moderate infections caused by susceptible strains of the designated micro-organisms in a number of conditions including, Pharyngitis / tonsillitis, community-acquired pneumonia, uncomplicated skin and skin structure infections and disseminated mycobacterial infections.