Teva Pharmaceutical Industries Ltd. has announced that the US FDA has granted final approval for the Company’s ANDA for Clarithromycin Extended Release Tablets, 500 mg.
Teva’s Clarithromycin Extended Release Tablets are the AB-rated generic equivalent of Abbott’s macrolide antibiotic Biaxin XL Filmtabs.
The brand product has annual sales of approximately $284 million.
Teva is currently involved in patent litigation with Abbott concerning this product.