Tacrolimus extended-release - Veloxis Pharmaceuticals

Drug Profile

Tacrolimus extended-release - Veloxis Pharmaceuticals

Alternative Names: Envarsus; EnvarsusXR; LCP-Tacro™; MeltDose® tacrolimus tablets; Tacrolimus extended release; Tacrolimus-ER

Latest Information Update: 23 Apr 2018

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At a glance

  • Originator LifeCycle Pharma
  • Developer Chiesi Farmaceutici; LifeCycle Pharma; Veloxis Pharmaceuticals
  • Class Lactones; Macrolides; Skin disorder therapies
  • Mechanism of Action Bone morphogenetic protein receptor type II modulators; Calcineurin inhibitors; Cytokine inhibitors; Immunosuppressants; T cell activation inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Renal transplant rejection
  • New Molecular Entity No
  • Available For Licensing Yes

Highest Development Phases

  • Marketed Allotransplant rejection; Liver transplant rejection; Renal transplant rejection; Transplant rejection
  • Discontinued Autoimmune hepatitis

Most Recent Events

  • 19 Apr 2018 FDA assigns PDUFA action date of 07/01/2019 for Tacrolimus extended release for Renal transplant rejection (Prevention, Treatment-naive)
  • 19 Apr 2018 US FDA accepts sNDA for Tacrolimus extended-release for Renal transplant rejection (Prevention, Treatment-naive) for review
  • 28 Mar 2018 Additional pharmacokinetic data from the phase IIIb ASERTAA study released by Veloxis Pharmaceuticals
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