FDA grants tentative approval for Teva's Cinacalcet HCl Tablets ANDA

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May 15 2010

Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVA) announced today that the U.S. Food and Drug Administration (FDA) has granted tentative approval for the 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 $458 million in the United States, based on IMS sales data.

Teva is currently involved in patent litigation concerning this product in the U.S. District Court for the District of Delaware. A trial date has not been set.

SOURCE Teva Pharmaceutical Industries Ltd.,

Posted in: Medical Condition News | Pharmaceutical News

Tags: Biotechnology, Chronic, Chronic Kidney Disease, Dialysis, Food, Hyperparathyroidism, Kidney, Kidney Disease, Medicaid, Medicare, Nephrology, Nephropathy, New Drug Application, Pharmaceuticals, Protonix

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