May 17, 2010 (FinancialWire) — Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) said that the U.S. Food and Drug Administration has granted tentative approval for the company's abbreviated new drug application 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 around $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.

Israel-based Teva Pharmaceutical Industries is a generic pharmaceutical company that develops, manufactures and markets pharmaceuticals and active pharmaceutical ingredients. Over 80 percent of Teva's sales are in North America and Western Europe.

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