Lupin gets USFDA nod for generic immunosuppressant capsules

Drug firm Lupin on Thursday said that in alliance with Concord Biotech, it has received approval from the US health regulator to market generic immunosuppressant Tacrolimus capsules used in the American market.

Drug firm Lupin on Thursday said that in alliance with Concord Biotech, it has received approval from the US health regulator to market generic immunosuppressant Tacrolimus capsules used in the American market. In alliance with Concord Biotech, the company has received approval from the United States Food and Drug Administration (USFDA) to market Tacrolimus capsules USP, in the strengths of 0.5 mg, 1 mg, and 5 mg, Lupin said in a filing to the BSE.

The product is a generic version of Astellas Pharma US, Inc's Prograf capsules in the same strengths, it added. According to IQVIA MAT September 2020 data, Tacrolimus capsules USP (0.5 mg, 1 mg, and 5 mg) had an annual sales of about USD 303 million in the US, Lupin said.

The capsules are indicated for the prophylaxis of organ rejection in adult and pediatric patients receiving allogeneic liver, kidney or heart transplants, in combination with other immunosuppressants, it added. Shares of Lupin Ltd on Thursday fell 1.76 per cent to Rs 897.70 per scrip on the BSE.

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