Ciclosporin ophthalmic - Allergan

Drug Profile

Ciclosporin ophthalmic - Allergan

Alternative Names: Cyclosporin - Allergan; Cyclosporin ophthalmic emulsion; Cyclosporine - Allergan; Restasis; RESTASIS MULTIDOSE; Restasis X

Latest Information Update: 12 Nov 2016

Price : $50

At a glance

  • Originator Novartis
  • Developer Allergan
  • Class Antineoplastics; Antipsoriatics; Antirheumatics; Ciclosporins; Eye disorder therapies; Neuroprotectants
  • Mechanism of Action Calcineurin inhibitors; Free radical inhibitors; Immunosuppressants; Mitochondrial permeability transition pore inhibitors; P-glycoprotein inhibitors
  • Orphan Drug Status

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

    No
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    No
  • New Molecular Entity No

Highest Development Phases

  • Marketed Dry eyes

Most Recent Events

  • 31 Oct 2016 US FDA approves multi-dose preservative-free formulation of cyclosporine ophthalmic emulsion 0.05% for Dry eyes
  • 10 Mar 2016 Allergan receives complete response letter from the US FDA for multi-dose preservative-free formulation of cyclosporine ophthalmic emulsion 0.05% in Dry eyes
  • 11 Nov 2015 Allergan submits a Prior Approval Supplement for a multi-preservative free formulation of ciclosporin ophthalmic 0.05% in USA
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