Pharma major Lupin on Thursday said its alliance partner Concord Biotech has received approval from the US health regulator for generic immunosuppressive Mycophenolic acid delayed-release tablets.
The approval from the United States Food and Drug Administration (USFDA) is to market Mycophenolic acid delayed-release tablets USP in the strengths of 180 mg and 360 mg, Lupin said in a statement.
The product is a generic version of Novartis Pharmaceuticals Corporation's Myfortic delayed-release tablets in the same strengths, it added.
According to IQVIA MAT September 2019 data, Mycophenolic acid delayed-release tablets USP, 180 mg and 360 mg had annual sales of around USD 174 million in the US market, Lupin said.
The tablets are indicated for prophylaxis of organ rejection in adult patients receiving kidney transplants and in pediatric patients at least 5 years of age and older who are at least 6 months post kidney transplant, it added.
Myfortic is to be used in combination with cyclosporine and corticosteroids, Lupin said.
Shares of Lupin Ltd closed at Rs 770.70 per scrip on BSE, up 0.60 per cent from its previous close.