Empagliflozin/metformin

Drug Profile

Empagliflozin/metformin

Alternative Names: BI-10773/metformin; Empagliflozin/metformin extended-release; Empagliflozin/metformin immediate-release; Metformin/BI-10773; Metformin/empagliflozin; Metformin/empagliflozin extended-release; Metformin/empagliflozin immediate-release; Metformin/empagliflozin XR; Synjardy; Synjardy XR

Latest Information Update: 01 Feb 2017

Price : $50

At a glance

  • Originator Boehringer Ingelheim
  • Developer Boehringer Ingelheim; Eli Lilly
  • Class Antihyperglycaemics; Benzhydryl compounds; Biguanides; Cyclic ethers; Glucosides; Small molecules
  • Mechanism of Action AMP activated protein kinase stimulants; Gluconeogenesis inhibitors; 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
  • 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 Type 2 diabetes mellitus

Most Recent Events

  • 26 Jan 2017 The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for change in the terms of the marketing authorisation of empagliflozin/metformin
  • 04 Jan 2017 US FDA approves sNDA to include data, demonstrating empagliflozin reduces the risk for cardiovascular death, in product labels for empagliflozin/metformin hydrochloride and empagliflozin/metformin hydrochloride extended-release tablets in USA
  • 12 Dec 2016 Registered for Type-2 diabetes mellitus in USA (PO, Extended release)
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