Drug Profile
Immune globulin - GC Biopharma
Alternative Names: ALYGLO; GC 5107; GC 5107B; GC-5101B; GC5107A; Human Immune Globulin Intravenous,10% Liquid; I.V.-Globulin SN inj.; IGIV-SN; IVIG 10%; IVIG-S 5%; IVIG-SN 5%Latest Information Update: 19 Dec 2023
Price :
$50
*
At a glance
- Originator Green Cross
- Developer GC Biopharma; GC Pharma
- Class Anti-infectives; Anti-inflammatories; Antibacterials; Antidementias; Antifibrotics; Antivirals; Eye disorder therapies; Immunoglobulins; Immunoproteins; Serum globulins; Skin disorder therapies; Vascular disorder therapies
- Mechanism of Action Amyloid beta-protein inhibitors; Immunostimulants
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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
- Marketed Agammaglobulinaemia; Guillain-Barre syndrome; Infections; Mucocutaneous lymph node syndrome
- Registered Immunodeficiency disorders
- Phase III Thrombocytopenia
Most Recent Events
- 17 Dec 2023 Registered for Immunodeficiency disorders in USA (IV)
- 31 Jul 2023 GC Biopharma anticipates the US FDA decision on the Biologics License Application (BLA) of GC5107B in Immunodeficiency disorders
- 31 Jul 2023 US FDA assigns a Prescription Drug User Fee Act (PDUFA) goal date for Biologics License Application in Immunodeficiency disorders in January 2024