Ranbaxy Laboratories is launching its approved generic formulation of Clarithromycin immediate release (IR) tablets, 250 mg and 500 mg, in the US, today.
The Office of Generic Drugs, US Food and Drug Administration, has determined that Ranbaxy's formulation can be expected to have the same therapeutic effect as an equivalent dose of Abbott's Biaxin Filmtab (Clarithromycin tablets, USP). Ranbaxy's Clarithromycin tablets will be manufactured and marketed under the Ranbaxy label. Total annual market sales for 250 mg and 500 mg of Biaxin Filmtab were $204.3 million (IMS - MAT: March 2005).
Clarithromycin tablets are indicated for the treatment of mild to moderate infections caused by susceptible strains of designated microorganisms.
Ranbaxy Pharmaceuticals Inc (RPI), based in Jacksonville, Florida, USA, is engaged in the sale and distribution of generic and branded prescription products in the US healthcare system.