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news.Teva Pharmaceutical, a generic pharmaceutical company that develops, manufactures and markets generic pharmaceuticals and active pharmaceutical ingredients, has received FDA tentative approval for its abbreviated new drug application (ANDA) for Cinacalcet HCl tablets 30mg, 60mg and 90mg
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Cinacalcet HCl is used to treat patients with chronic kidney disease who are on dialysis. It is also used to treat patients with cancer of the parathyroid gland. It lowers parathyroid hormone (PTH) levels by increasing sensitivity of calcium-sensing receptor to extracellular calcium.
Teva Pharmaceutical has claimed that, upon final approval, its Cinacalcet HCl tablets are expected to 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.
Teva Pharmaceutical 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.