www.fdanews.com/articles/72652-teva-receives-approval-for-generic-biaxin
Teva Receives Approval for Generic Biaxin
May 24, 2005
Teva Pharmaceutical has received final approval from the FDA for its abbreviated new drug application for clarithromycin extended-release tablets in a 500-mg dosage form.
Teva's tablets are the generic equivalent of Abbott's antibiotic Biaxin XL filmtabs. The brand product has annual sales of roughly $284 million, according to Teva.