Lupin gets UAFDA approval for Cinacalcet Tablets

Lupin announced that it has received approval for its Cinacalcet Tablets, 30 mg, 60 mg, and 90 mg from the United States Food and Drug Administration (U.S. FDA).

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
- severe hypercalcemia in adult patients with primary HPT who are unable to undergo parathyroidectomy

Cinaca lcet Tablets, 30 mg, 60 mg, and 90 mg, had annual sales of approximately USD 1527 million in the US (IQVIA MAT March 2019).

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