Veloxis' Tacrolimus Clears FDA For Narrower Population Following Court Loss
This article was originally published in The Pink Sheet Daily
Executive Summary
Envarsus XR, a once-daily version of the immunosuppressant, is approved for kidney transplant patients seeking to convert from twice-daily formulations; a claim for use in newly transplanted, 'de novo' patients was blocked by Astellas' three-year exclusivity on Astagraf.
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