Drug major Lupin has received final approval from the US health regulator to market Potassium Chloride extended release capsules, used to treat potassium deficiency in the body, in the American market.
The company has received final approval for its Potassium Chloride extended release capsules from the United States Food and Drug Administration (USFDA), Lupin said in a statement.
“Lupin’s US subsidiary, Lupin Pharmaceuticals Inc shall commence promoting the product in the US shortly,” it added.
Lupin’s product is the generic equivalent of Actavis Labs Inc’s Potassium Chloride extended release capsules, which is indicated for the treatment of patients with hypokalemia.
According to IMS MAT September 2015 sales data, Potassium Chloride extended release capsules had US sales of $85.6 million.
The Mumbai-based firm has launched 8 products in the US market so far this fiscal, and received approvals for 18 from the USFDA.
Lupin shares today ended 1.02 per cent up at Rs 1,804.05 apiece on BSE.