Ranbaxy first to get OK for clarithromycin oral susp generic in USA

Ranbaxy Pharmaceuticals, a wholly-owned US subsidiary of India's Ranbaxy Laboratories, has received final approval from the Food and Drug Administration to manufacture and market clarithromycin for oral suspension, USP, 125mg/5mL and 250mg/5mL. Ranbaxy is the first company to have been granted a generic approval for this form along with clarithromycin tablets. Total annual market sales for clarithromycin were $99.7 million with suspension turnover totaling $25.3 million, according to IMS Health data for the 12 months to June.

The firm will be in a position to offer both dosage forms for this molecule that will distinguish Ranbaxy in the market place, says Jim Meehan, vice president of sales and distribution. "This approval further expands our product portfolio of affordable generic alternatives and will be shipped immediately to all classes of trade," he added.

The FDA's Office of Generic Drugs has determined the Ranbaxy formulation to be bioequivalent and to have the same therapeutic effect as that of the reference listed drug, Abbott Laboratories' Biaxin granules, the generics firm notes.