The tablets are indicated for prophylaxis of organ rejection in adult patients receiving kidney transplants
Lupin 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 (US FDA) 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 $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 paediatric patients at least five years of age and older who are at least six months post kidney transplant, it added.
Myfortic is to be used in combination with cyclosporine and corticosteroids, Lupin said.
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