Strides Arcolab gets US drug regulator nod for Calcitriol softgel capsules

NEW DELHI: Strides Arcolab has received approval from the US drug regulator for Calcitriol softgel capsules used for treatment of patients with kidney disease who have vitamin D deficiency.

The company has received approval from the United States Food & Drug Administration (USFDA) for Calcitriol softgel capsules in the strengths of 0.25mcg and 0.5mcg, Strides Arcolab said in a statement.

"According to IMS data, the US market for generic Calcitriol softgel capsules is approximately USD 50 million, with only three players having approval for both the strengths of Calcitriol," it added.

The product will be manufactured at the company's oral dosage facility at Bengaluru and marketed in the US market, Strides Arcolab said.

"Calcitriol is a Vitamin D capsule, used in patients with kidney disease who can't make enough of the active form of Vitamin D... It is usually used along with specific diet recommendations and sometimes other medications," it added.

Strides Arcolab scrip closed at Rs 888.75, down 3.57 per cent, on the BSE.