Proper Name: Immune Globulin Intravenous, Human-slra, 10% Liquid
Manufacturer: ADMA Biologics, Inc.
- Indicated for the treatment of primary humoral immunodeficiency for adults and adolescents (12 to 17 years of age).
- Package Insert - ASCENIV
- Demographic Subgroup Information - ASCENIV (immune globulin intravenous, human – slra) 10% Liquid
Refer to Section 1.1 of the Clinical Review Memo for information about participation in the clinical trials and any analysis of demographic subgroup outcomes that is notable.
- April 1, 2019 Approval Letter - ASCENIV
- Statistical Review - ASCENIV
- Approval History, Letters, Reviews and Related Documents - ASCENIV