Bivigam FDA Approval History
FDA Approved: Yes (First approved December 21, 2012)
Brand name: Bivigam
Generic name: immune globulin intravenous
Dosage form: Infusion
Company: Biotest Pharmaceuticals Corporation
Treatment for: Primary Immunodeficiency Syndrome
Bivigam is an immune globulin intravenous (human) indicated for the treatment of primary humoral immunodeficiency.
Development timeline for Bivigam
| Date | Article |
|---|---|
| Dec 12, 2023 | Approval ADMA Biologics Announces FDA Approval for Bivigam in the Pediatric Patient Setting for Those 2 Years of Age and Older |
| Dec 13, 2022 | Approval ADMA Biologics Announces FDA Approval for Room Temperature Storage of Asceniv & Bivigam |
| May 10, 2019 | Approval ADMA Announces It Will Reintroduce Bivigam Into the Market |
| Dec 21, 2012 | Approval FDA Approves Biotest's Bivigam, an Intravenous Immune Globulin (Human), 10% Liquid |
Further information
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