Mylan receives FDA approval for generic Prograf

PITTSBURGH The Food and Drug Administration has approved a generic treatment for organ transplant patients.


Mylan announced Tuesday the approval of tacrolimus capsules in the 0.5-mg, 1-mg and 5-mg strengths, and said it plans to launch the drug immediately. The drug is used to prevent rejection of transplanted organs.



Tacrolimus capsules are a generic version of Astellas’ Prograf. The branded version of the drug and generic versions had sales of around $944 million during the 12-month period ended in June, according to IMS Health.


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