ASCENIV
STN: 125590
Proper Name: Immune Globulin Intravenous, Human-slra
Tradename: ASCENIV
Manufacturer: ADMA Biologics, Inc.
Indication:
- For intravenous injection, indicated for the treatment of primary humoral immunodeficiency (PI) in adults and adolescents (12 to 17 years of age).
Product Information
- 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.
Supporting Documents
- 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