Ranbaxy launches clarithromycin tablets in US

EPP News Bureau - New Delhi

Ranbaxy Laboratories Limited has launched its approved generic formulation of clarithromycin immediate release tablets in the US, according to a press release.

The Office of Generic Drugs, US Food and Drug Administration (FDA), 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—250 mg and 500 mg—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), according to the release.

Clarithromycin tablets are indicated for the treatment of mild to moderate infections caused by susceptible strains of designated micro-organisms. In response to the approval and launch, Jim Meehan, vice-president of Sales and Marketing for Ranbaxy Pharmaceuticals Inc (RPI) stated, ‘‘We are delighted to market this product as an addition to our ever growing generic product portfolio. Our plans are to bring this product to the market immediately.’’

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