FDA OKs Aurobindo’s generic Sensipar

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FDA OKs Aurobindo’s generic Sensipar

By Sandra Levy - 08/27/2019
Aurobindo has received the Food and Drug Administration's approval for cinacalcet hydrochloride tablets in dosage strengths of 30 mg, 60 mg, and 90 mg.

Aurobindo’s product is the generic of Amgen’s Sensipar.

Cinacalcet hydrochloride tablets are indicated for the treatment of secondary hyperparathyroidism, or 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 hydrochloride tablets had a market value of approximately $1.45 billion for the 12 months ended May 2019, according to IQVIA.

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