Proper Name: Immune Globulin Intravenous, Human-slra
Manufacturer: ADMA Biologics, Inc.
- Treatment of Primary Immunodeficiency Diseases (PIDD)
- 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.
- December 7, 2022 Approval Letter - ASCENIV
- April 1, 2019 Approval Letter - ASCENIV
- Statistical Review - ASCENIV
- Approval History, Letters, Reviews and Related Documents - ASCENIV