RI 002

Drug Profile

RI 002

Alternative Names: IGIV - ADMA Biologics; Immune globulin intravenous - ADMA Biologics; Respiratory syncytial virus immune globulin - ADMA Biologics; RI-001; RI-002

Latest Information Update: 24 Oct 2018

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At a glance

  • Originator ADMA Biologics; Baylor College of Medicine
  • Developer ADMA Biologics
  • Class Antivirals; Immunoglobulins; Immunoproteins; Serum globulins
  • Mechanism of Action Immunostimulants
  • Orphan Drug Status

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

    No
  • New Molecular Entity No

Highest Development Phases

  • Preregistration Immunodeficiency disorders

Most Recent Events

  • 24 Oct 2018 Planned Prescription Drug User Fee Act (PDUFA) date for Immunodeficiency disorders in USA (IV) is 2019-04-02
  • 17 Oct 2018 Preregistration for Immunodeficiency disorders in USA (IV)
  • 17 Oct 2018 The US FDA accepts resubmission of BLA for RI 002 for Immunodeficiency disorders for review
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