Lupin, Concord Biotech get US FDA nod for generic immunosuppressant tabs
The capsules are indicated for the prophylaxis of organ rejection in adult and paediatric patients receiving allogeneic liver, heart or kidney transplant
Lupin stated that in alliance with Concord Biotech, it has obtained acceptance from the US health regulator to market generic immunosuppressant Tacrolimus capsules used in the Western industry.
In cooperation with Concord Biotech, the business has obtained approval from the United States Food and Drug Administration (US FDA) to advertise Tacrolimus capsules USP, at the advantages of 0.5 mg, 1 mg, and 5 milligrams, Lupin said in a filing to the BSE.
The product is a standard version of Astellas Pharma US’ Prograf capsules at exactly the very same strengths, it added.
According to IQVIA MAT September 2020 data, Tacrolimus capsules USP (0.5 mg, 1 mg, and 5 mg) had an yearly sales of about USD 303 million at the united states, Lupin explained.
The capsules are indicated for the prophylaxis of organ rejection in adult and paediatric patients receiving allogeneic liver, heart or kidney transplant, in conjunction with other immunosuppressants, it included.
PTI
