New Delhi: Drug firm Strides Shasun said its wholly-owned subsidiary Strides Pharma Global has received approval from the US health regulator for Cinacalcet Hydrochloride tablets, used for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease on dialysis.
In a BSE filing, Strides Shasun said “its wholly owned subsidiary Strides Pharma Global Pte. Limited has received final approval for Cinacalcet Hydrochloride tablets, 30 mg (base), 60 mg (base), and 90 mg (base) from the United States Food and Drug Administration (USFDA)”.
Cinacalcet Hydrochloride tablets is a generic version of Sensipar tablets of Amgen Inc.
Citing IQVIA data, the company said the US market for the approved product is approximately USD 1.8 billion.
The product will be manufactured at the company’s oral dosage facility at Puducherry and will be marketed by Strides Pharma Inc. in the US Market.