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Ceftobiprole medocaril - Basilea Pharmaceutica

Drug Profile

Ceftobiprole medocaril - Basilea Pharmaceutica

Alternative Names: BAL-5788; BAL-9141; Ceftobiprole; Ceftobiprole medocaril sodium; JNJ-30982081; Mabelio; RO-65-5788; Zeftera; Zevtera

Latest Information Update: 05 Nov 2023

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At a glance

  • Originator Basilea Pharmaceutica
  • Developer Avir Pharma; Basilea Pharmaceutica; Department of Health & Human Services; Hikma Pharmaceuticals; Janssen Research & Development; Janssen-Cilag; Johnson & Johnson Pharmaceutical Research & Development; Knight Therapeutics; Shenzhen China Resources Gosun Pharmaceutical
  • Class Antibacterials; Cephalosporins; Skin disorder therapies; Small molecules
  • Mechanism of Action Cell wall inhibitors; Peptidyltransferase 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
  • Available For Licensing Yes - Bacteraemia; Community-acquired pneumonia; Skin and soft tissue infections

Highest Development Phases

  • Marketed Community-acquired pneumonia; Nosocomial pneumonia
  • Registered Bacteraemia
  • Preregistration Skin and soft tissue infections
  • Phase III Bacterial infections
  • No development reported Paediatric infections

Most Recent Events

  • 02 Oct 2023 U.S. Food and Drug Administration (FDA) accepts a New Drug Application (NDA) for ceftobiprole for Bacteraemia, Skin and soft tissue infections, and Community-acquired pneumonia
  • 02 Oct 2023 US FDA assigns PDUFA action date of 03/April/2024 for ceftobiprole for Bacteraemia, Skin and soft tissue infections, and Community-acquired pneumonia
  • 28 Sep 2023 Efficacy data from a phase III ERADICATE trial in Bacteraemia released by Basilea Pharmaceutica
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