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Immune globulin - ADMA Biologics

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Drug Profile

Immune globulin - ADMA Biologics

Alternative Names: ASCENIV; IGIV - ADMA Biologics; Immune globulin intravenous human - ADMA Biologics; Immune globulin intravenous, human – slra; Respiratory syncytial virus immune globulin - ADMA Biologics; RI-001; RI-002

Latest Information Update: 13 Nov 2024

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At a glance

  • Originator ADMA Biologics; Baylor College of Medicine
  • Developer ADMA Biologics
  • Class Anti-infectives; Anti-inflammatories; Antibacterials; Antidementias; Antifibrotics; Antivirals; Eye disorder therapies; Immunoglobulins; Immunoproteins; Polyethylene glycols; Serum globulins; Skin disorder therapies; Vascular disorder therapies
  • 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

  • Marketed Immunodeficiency disorders
  • No development reported Respiratory syncytial virus infections

Most Recent Events

  • 07 Nov 2024 ADMA Biologics announces intention to submit sBLA to US FDA for Immunodeficiency disorders (In children) in USA in 2024-2025
  • 07 Nov 2024 ADMA Biologics anticipates approval of sBLA for Immunodeficiency disorders (In children) in USA in the first half of 2026
  • 13 Dec 2022 US FDA approves of room temperature (25°C) storage for ASCENIV and BIVIGAM

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