Lupin partner Concord gets USFDA nod for generic version of Myfortic tablets

Mycophenolic acid delayed-release tablet is a generic version of Novartis Pharmaceuticals Corporation's Myfortic delayed-release tablets in the same strengths, Lupin added.

New Delhi: 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.

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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.

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