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Delafloxacin - Melinta Therapeutics/Wakunaga Pharmaceutical

Drug Profile

Delafloxacin - Melinta Therapeutics/Wakunaga Pharmaceutical

Alternative Names: ABT-492; Baxdela; Quofenix; RX-3341; RX-3341-83; WQ-3034

Latest Information Update: 28 Nov 2019

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At a glance

  • Originator Wakunaga Pharmaceutical
  • Developer Abbott Laboratories; Eurofarma; Melinta Therapeutics; Menarini
  • Class Anti-infectives; Antibacterials; Azetidines; Fluoroquinolones; Pyridines; Small molecules
  • Mechanism of Action DNA gyrase inhibitors; DNA topoisomerase IV 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 Yes

Highest Development Phases

  • Marketed Skin and soft tissue infections
  • Registered Community-acquired pneumonia
  • No development reported Urinary tract infections
  • Discontinued Acute exacerbations of chronic bronchitis; Anthrax; Gonorrhoea; Intra-abdominal infections

Most Recent Events

  • 28 Nov 2019 No recent reports of development identified for phase-I development in Urinary-tract-infections(Complicated) in USA
  • 30 Oct 2019 The Committee for Medicinal Products for Human Use adopts positive opinion recommending approval of delafloxacin for Skin and soft tissue infections in European union, before October 2019
  • 25 Oct 2019 Planned Prescription Drug User Fee Act (PDUFA) date for Community-acquired pneumonia (In adults) in USA (PO) is 2019-10-24
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