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Fidaxomicin - Merck

Drug Profile

Fidaxomicin - Merck

Alternative Names: Dafclir; Dificid; Dificlir; Difimicin; Lipiarmycin; OPT-80; PAR-101; Tiacumicin-B

Latest Information Update: 04 Oct 2019

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At a glance

  • Originator Optimer Pharmaceuticals
  • Developer Astellas Pharma; Astellas Pharma Europe Ltd; Merck & Co; Optimer Pharmaceuticals
  • Class Antibacterials; Glycosides; Macrocyclic compounds; Small molecules
  • Mechanism of Action DNA-directed RNA polymerase inhibitors
  • Orphan Drug Status

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

    Yes - Clostridium difficile infections
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Clostridium difficile infections
  • Discontinued Methicillin-resistant Staphylococcus aureus infections

Most Recent Events

  • 03 Oct 2019 Preregistration for Clostridium difficile infections (In adolescents, In children, In infants) in USA (PO, Suspension)
  • 03 Oct 2019 The US FDA accepts sNDA for fidaxomicin for Clostridium (Clostridioides) difficile infections (In infants, In children, In adolescents) for review (PO, Tablets and Suspension)
  • 02 Oct 2019 FDA assigns PDUFA action date of 24/01/2020 for fidaxomicin for Clostridium difficile infections (In adolescents, In children, In infants) (PO, Suspension, Tablet)
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