The office of generic drugs, US Food and Drug Administration has determined that Ranbaxy's Clarithromycin tablets of 250 mg and 500 mg formulation can be expected to have the same therapeutic effect as an equivalent dose of Abbott's Biaxin Filmtab, the company informed the Bombay Stock Exchange.
"Our plans are to bring this product to the market immediately," Jim Meehan, vice-president, sales and marketing, Ranbaxy Pharmaceuticals Inc, said.
The company's Clarithromycin tablets will be manufactured and marketed under the Ranbaxy label, it said.
The total annual market sales for 250 mg and 500 mg of Biaxin Filmtab were $204.3 million (according to IMS - MAT: March 2005).
Clarithromycin tablets are indicated for the treatment of mild to moderate infections caused by susceptible strains of designated micro-organisms.
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