Teva Pharmaceutical Industries Ltd. has announced that the US FDA has granted final approval for the company’s ANDA for Clarithromycin Tablets USP, 250 mg and 500 mg.
Teva’s Clarithromycin Tablets are the AB-rated generic equivalent of Abbott’s antibiotic Biaxin Tablets. The brand product has annual sales of approximately $204 million.
Teva is currently involved in patent litigation with Abbott concerning this product.