Teva Pharmaceutical Industries Ltd has received tentative approval from US Food and Drug Administration (FDA) for company's Abbreviated New Drug Application (ANDA) for Cinacalcet HCl Tablets 30, 60 & 90 mg.
Upon final approval, Teva's Cinacalcet HCl Tablets will be the AB-rated generic equivalent of Amgen's Sensipar, indicated for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis.
The brand product had annual sales of approximately US$ 458 million in the United States, based on IMS sales data.
Teva is currently involved in patent litigation concerning this product in the US District Court for the District of Delaware. A trial date has not been set.
Teva Pharmaceutical Industries Ltd, headquartered in Israel, is among the top 15 pharmaceutical companies in the world and is the leading generic pharmaceutical company.