| Ranbaxy gets US FDA nod for Clarithromycin OS |
| BS Reporter / Mumbai October 4, 2007 |
| Ranbaxy Laboratories has received final approval from the US Food and Drug Administration (US FDA) to manufacture and market Clarithromycin for Oral Suspension (OS), USP, 125 mg/5 ml and 250 mg/5 ml. According to an official release issued by the company to the BSE today, it is the first to have been granted a generic approval for the oral suspension form along with Clarithromycin tablets. "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," Jim Meehan, VP (sales & distribution), 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 |
