Rifamycin controlled-release - Cosmo/Salix/Dr Falk Pharma

Drug Profile

Rifamycin controlled-release - Cosmo/Salix/Dr Falk Pharma

Alternative Names: Aemcolo; CB-01-11; M-14; Rifamycin controlled release; Rifamycin CR; Rifamycin SV; Rifamycin SV MMX; Rifamycin-sodium; Rifamycin-SV-sodium

Latest Information Update: 30 Jul 2018

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At a glance

  • Originator Cosmo Pharmaceuticals
  • Developer Cosmo Pharmaceuticals; Dr Falk Pharma; Salix Pharmaceuticals
  • Class Antibacterials; Antirheumatics; Antituberculars; Rifamycins
  • 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.

  • New Molecular Entity No

Highest Development Phases

  • Preregistration Traveller's diarrhoea
  • Phase II Diverticulitis; Irritable bowel syndrome
  • Discontinued Clostridium-difficile-infections

Most Recent Events

  • 21 May 2018 The US FDA sets PDUFA date of November 16, 2018 for NDA review for traveller's diarrhea
  • 21 May 2018 The US FDA accepts NDA for controlled release rifamycin for Traveller's diarrhoea for review
  • 22 Mar 2018 Preregistration for Traveller's diarrhoea in European Union (PO)
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