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Andrx gets US FDA approval for Clarithromycin
Fort Lauderadale | Tuesday, June 29, 2004, 08:00 Hrs  [IST]

Andrx Corporation announced that the US FDA has approved the Company's abbreviated new drug application (ANDA) for Clarithromycin Extended-release tablets, 500mg, an antibiotic, which is bioequivalent to Abbott Laboratories Inc's Biaxin XL Filmtab.

The brand product had approximately $280 million of sales in 2003, according to IMS data. Andrx does not plan to launch its generic version of Biaxin XL Filmtab prior to the expiration of a May 2005 patent.

Larry Rosenthal, Andrx Pharmaceuticals, Inc Ppesident stated, "We are pleased to be the recipient of the first ANDA approval for Biaxin XL Filmtab.

Andrx Corporation is a pharmaceutical company that develops and commercializes generic versions of controlled-release brand name pharmaceuticals.

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