Date:28/09/2004 URL: http://www.thehindubusinessline.com/2004/09/28/stories/2004092801490200.htm

Back Ranbaxy gets US FDA nod for Clarithromycin

Our Bureau

New Delhi , Sept. 27

RANBAXY Laboratories Ltd has received approval from the US Food and Drug Administration (FDA) to manufacture and market Clarithromycin tablets 250 mg and 500 mg used for treating infections.

According to a company statement, the Office of Generic Drugs has determined the Ranbaxy formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug — Abbott Laboratories' Biaxin tablets. The total market sales for Clarithromycin are around $554 million.

Clarithromycin tablets are indicated for the treatment of mild to moderate infections caused by susceptible strains of the designated micro-organisms in the throat, lungs and even skin.

"We are planning to commercialise Clarithromycin tablets after the expiration of US patent in May 2005," said Mr Jay Deshmukh, Vice-President of Intellectual Property, Ranbaxy Laboratories.