Canagliflozin/metformin extended-release - Depomed/Janssen

Drug Profile

Canagliflozin/metformin extended-release - Depomed/Janssen

Alternative Names: CANA/MET XR FDC; Invokamet XR; Metformin extended-release/canagliflozin - Depomed/Janssen

Latest Information Update: 19 Jul 2018

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At a glance

  • Originator Depomed; Janssen Pharmaceutica
  • Class Antihyperglycaemics; Biguanides; Glucosides; Small molecules; Thiophenes
  • Mechanism of Action AMP activated protein kinase stimulants; Gluconeogenesis inhibitors; Glucose modulators; Sodium-glucose transporter 2 inhibitors
  • Orphan Drug Status

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

    No
  • New Molecular Entity No

Highest Development Phases

  • Marketed Type 2 diabetes mellitus

Most Recent Events

  • 13 Jul 2018 US FDA assigns PDUFA action date of 31/10/2018 for canagliflozin for the sNDA to reduce the risk of major adverse cardiovascular events in Type-2 diabetes mellitus
  • 13 Jul 2018 US FDA extends the review timeline for the sNDA to reduce the risk of major adverse cardiovascular events in Type 2 diabetes mellitus
  • 02 Oct 2017 Janssen Research and Development files sNDA to reduce the risk of major adverse cardiovascular events composed of cardiovascular death, myocardial infarction and stroke patients with Type 2 diabetes mellitus in USA
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