TheraRadar
Data updated: May 26, 2026

Bivigam (immune globulin intravenous (human))

Approved 2012-12-18
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
13
Years on Market

Details

Status
Prescription
First Approved
2012-12-18
Routes
Intravenous
Dosage Forms
Injection

Companies

ADMA Biologics
Active Ingredient: Immune Globulin Intravenous (Human) , Immune Globulin Intravenous (Human)

Bivigam Approval History

2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2012 to 2012
Dec 2012 ORIGINAL
Update · CBER biologic (Purple Book)

What Bivigam Treats

1 FDA approvals

Originally approved for its first indication in 2012 .

  • Other (1)
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Clinical Trial Registry

2 trials
Trial Sponsor ID Phase Status Title
NCT05832034 TIMEISMUSCLE NL74270.018.20 Ph 2, Ph 3 active not recruiting Add-on Intravenous Immunoglobulins in Early Myositis
NCT03164967 994 Ph 4 completed Study to Evaluate Safety and Pharmacokinetics of BIVIGAM® in Primary Immune Deficiency Subjects Aged 2 to 16
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

Bivigam FDA Label Details

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Data Sources

FDA Approval: BLA125389 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.