East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application for Cinacalcet Hydrochloride Tablets, 30mg, 60mg, and 90mg. Aurobindo’s Cinacalcet Hydrochloride Tablets are an AB-rated generic equivalent to the reference listed drug, Amgen Inc’s Sensipar.

Cinacalcet Hydrochloride tablets are indicated for the treatment of:

• Secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis
• Hypercalcemia in adult patients with parathyroid carcinoma
• Severe hypercalcemia in adult patients with primary HPT who are unable to undergo parathyroidectomy

Cinacalcet Hydrochloride tablets had an annual sale of approximately US $1.45 Billion for the twelve months ending May 2019 as per IQVIA.