US FDA approves Lupin's cinacalcet tablets

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The United States Food and Drug Administration (FDA) has approved Lupin's cinacalcet tablets, 30 mg, 60 mg, and 90 mg.

Lupin’s cinacalcet tablets, 30 mg, 60 mg, and 90 mg, is the generic version of Sensipar tablets, 30 mg, 60 mg, and 90 mg, of Amgen Inc.

It is indicated in the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease on dialysis, hypercalcemia in adult patients with parathyroid carcinoma and severe hypercalcemia in adult patients with primary HPT who are unable to undergo parathyroidectomy.

Cinacalcet tablets, 30 mg, 60 mg, and 90 mg, had annual sales of approximately US$ 1527 million in the US (IQVIA MAT March 2019).

http://www.pharmabiz.com/NewsDetails.aspx?aid=116716&sid=2

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