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.