The US Food and Drug Administration has granted tentative approval for Teva Pharmaceuticals' ANDA for rabeprazole sodium delayed-release tablets, 20 mg.

Upon final approval, Teva's rabeprazole sodium delayed-release tablets will be the AB-rated generic equivalent of Eisai's acid pump inhibitor Aciphex tablets, claims the company release

The brand product has annual sales of approximately $1.2 billion.

Teva is currently in patent litigation concerning this product in the US District Court for the Southern District of New York. Final approval of this ANDA is expected upon the earlier of a favourable decision in the case or expiry of the mandatory stay of approval in February 2007.

Teva Pharmaceutical Industries Ltd is among the top 20 pharmaceutical companies in the world and is the leading generic pharmaceutical company. The company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients, as well as animal health pharmaceutical products.