FDA clears first 2 generics of Sensipar
The Food and Drug Administration on Thursday approved the first generics of Amgen’s Sensipar. The generic Sensipar tablets (cinacalcet hydrochloride) — from Aurobindo and Cipla — mark the ninth and 10th approvals this year of first-time generics from the FDA.
Both Aurobindo’s and Cipla’s generic Sensipar will be available in 30-, 60- and 90-mg dosage strengths.
The drug is indicated to treat secondary hyperparathyroidism in adult patients with chronic kidney disease on dialysis, Hypercalcemia in adult patients with Parathyroid Carcinoma (PC), and severe hypercalcemia in adult patients with primary HPT who are unable to undergo parathyroidectomy.
Both Aurobindo’s and Cipla’s generic Sensipar will be available in 30-, 60- and 90-mg dosage strengths.
The drug is indicated to treat secondary hyperparathyroidism in adult patients with chronic kidney disease on dialysis, Hypercalcemia in adult patients with Parathyroid Carcinoma (PC), and severe hypercalcemia in adult patients with primary HPT who are unable to undergo parathyroidectomy.