What is FOSTAMATINIB DISODIUM used for?

FOSTAMATINIB DISODIUM is an FDA-approved medication. See full prescribing information for approved uses.

Is FOSTAMATINIB DISODIUM FDA approved?

Yes, FOSTAMATINIB DISODIUM is FDA approved (first approved 2018-04-17) and manufactured by ANNORA PHARMA.

Who makes FOSTAMATINIB DISODIUM?

FOSTAMATINIB DISODIUM is manufactured by ANNORA PHARMA.

Data updated: Jun 28, 2026

FOSTAMATINIB DISODIUM

Approved 2018-04-17

Jump to: Indications Approvals Trials Competitors Safety Patents

Indication

Phase 3 Trials

Years on Market

Details

Status: Prescription
First Approved: 2018-04-17
Routes: ORAL
Dosage Forms: TABLET

Companies

ANNORA PHARMA

Active Ingredient: FOSTAMATINIB DISODIUM

FOSTAMATINIB DISODIUM Approval History

Original

New Indication

New Form

Label Update

2 FDA actions from 2026 to 2026

Jun 2026 ORIGINAL

Update

What FOSTAMATINIB DISODIUM Treats

1 FDA approvals

Originally approved for its first indication in 2026 .

Other (1)

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Clinical Trial Registry

7 trials

Trial	Sponsor ID	Phase	Status	Title
NCT02077192 results posted	C-935788-049 2013-005454-30	Ph 3	completed	Open Label Study of R788 in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura (ITP)
NCT03764618 results posted	C-935788-057	Ph 3	completed	A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of wAIHA
NCT04138927	C-935788-058	Ph 3	enrolling by invitation	A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia
NCT02076399 FIT results posted	C-935788-047 2013-005452-15	Ph 3	completed	A Efficacy and Safety Study of R935788 in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura (ITP)
NCT02076412 FIT results posted	C-935788-048 2013-005453-76	Ph 3	completed	A Efficacy and Safety Study of Fostamatinib in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura (ITP)
NCT00798096 results posted	D4300C00024 C-935788-017	Ph 2	completed	Efficacy and Safety Study of Fostamatinib Disodium Tablets to Treat T-Cell Lymphoma
NCT00923481 results posted	090138 09-C-0138	Ph 2	completed	A Broad Multi-histology Phase II Study of the Multi-Kinase Inhibitor R935788 (Fostamatinib Disodium) in Advanced Colorectal, Non-small Cell Lung, Head and Neck Hepatocellular and Renal Cell Carcinomas, and Pheochromocytoma and Thyroid Tumors (Multi-H...

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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

| Show all trials (incl. adjuvant)

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.

FOSTAMATINIB DISODIUM FDA Label Details

Looking for the branded version?

TAVALISSE

Full clinical data, patents, trials, and competitive landscape for fostamatinib disodium.

See TAVALISSE

Data Sources

FDA Approval: ANDA217329 → Trials: ClinicalTrials.gov →

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