ASCENIV
STN: 125590
Proper Name: Immune Globulin Intravenous, Human-slra
Tradename: ASCENIV
Manufacturer: ADMA Biologics, Inc.
Indication:
- For the treatment of primary humoral immunodeficiency (PI) in adults and pediatric patients 2 years of age and older
- 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 30, 2026 Approval Letter - ASCENIV
- April 29, 2026 Clinical and Clinical Pharmacology Review Memo - ASCENIV
- Statistical Review - ASCENIV (125590/190)
- March 1, 2024 Approval Letter - ASCENIV
- September 11, 2023 Approval Letter - ASCENIV
- December 7, 2022 Approval Letter - ASCENIV
- April 1, 2019 Approval Letter - ASCENIV
- Statistical Review - ASCENIV
- Approval History, Letters, Reviews and Related Documents - ASCENIV