Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
Pediatric Studies Characteristics - Detail
FDA Home
Pediatrics
Pediatric Studies Characteristics
Detail
-
Please note:
JavaScript must be enabled for this application to work properly.
Check your settings
if you are unsure if your JavaScript is enabled.
Approval Date:
07/22/2011
Trade Name:
GAMMAGARD LIQUID
Generic or Proper Name (*):
Immune Globulin Infusion (Human)*
Indications Studied:
Treatment of patients with primary immunodeficiency associated with defects in humoral immunity in adults and pediatric patients two years of age or older
Therapeutic Category:
Immunomodulator
Ages Studied:
2 - < 16 years
Study #:
1
Study Type:
Pharmacokinetic/Tolerability
Study Design:
Open-label, Uncontrolled, Randomized, Phase III, Multi-center
No Patients:
61
No Centers:
9
No Countries:
1
BPCA(B), PREA(P):
P
-
-