Lupin gets USFDA nod to market generic injection for kidney disease

Drug firm Lupin Monday said it has received approval from the US health regulator to market its generic Doxercalciferol injection in the American market.

The company has received approval from the United States Food and Drug Administration (USFDA) to market its Doxercalciferol injection, 4 mcg/2 mL (2 mcg/mL) multi-dose vials, Lupin said in a statement.

The product is a generic version of Sanofi Genzyme's Hectorol injection, it added.

As per the IQVIA MAT September 2018 data, Doxercalciferol injection, 4 mcg/2 mL (2 mcg/mL) multi-dose vials had annual sales of around USD 133 million in the US, Lupin said.

The product is indicated for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis, it added.

Shares of Lupin were trading at Rs 853.60 per scrip on BSE, up 0.49 per cent from their previous close.