Data updated: May 26, 2026
Panzyga (immune globulin intravenous (human)-ifas)
Approved 2018-08-01
1
Indication
--
Phase 3 Trials
7
Years on Market
Details
- Status
- Prescription
- First Approved
- 2018-08-01
- Routes
- Intravenous
- Dosage Forms
- Injection
Panzyga Approval History
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2018 to 2018
Aug 2018 ORIGINAL
Update · CBER biologic (Purple Book)
What Panzyga Treats
1 FDA approvalsOriginally approved for its first indication in 2018 .
- Other (1)
Other
(1 approval)- • Approved indication (Aug 2018)
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Clinical Trial Registry
4 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04508530 results posted | NGAM-13 | Ph 3 | completed | Phase III Study To Compare The Effect of Panzyga Versus Placebo in Patients With Pediatric Acute-onset Neuropsychiatric Syndrome (PANS/PANDAS) |
| NCT04502030 | NGAM-12 | Ph 3 | completed | Double-blind, Randomized, Placebo-controlled, Prospective Phase III Study Evaluating Efficacy and Safety of Panzyga in Primary Infection Prophylaxis in Patients With Chronic Lymphocytic Leukemia ("PRO-SID" Study) |
| NCT04929236 | NGAM-11 | Ph 3 | recruiting | Study to Evaluate Safety and Efficacy of Different PANZYGA Dose Regimens in Pediatric Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) Patients |
| NCT03866798 results posted | NGAM-10 | Ph 4 | terminated | Study to Evaluate the Efficacy and Safety of PANZYGA in Pediatric Patients With Chronic Immune Thrombocytopenia (ITP) |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
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.
Panzyga FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.