Treats thrombocytopenia. NDA 209299, held by Rigel Pharms. Fostamatinib Disodium.
As of Nov 13, 2026, NDA 209299 (Tavalisse), held by Rigel Pharms, was first approved by FDA on Apr 17, 2018, with 1 approved supplement and 0 published complete response letters.
TAVALISSE is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 17, 2018 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| TavalisseEQ 100MG BASE · tablet;oral | Fostamatinib Disodium | RxReference drug |
| TavalisseEQ 150MG BASE · tablet;oral | Fostamatinib Disodium | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 4, 2025 | Supplement 3Labeling · Standard review | Approved | |
| Apr 17, 2018 | Original applicationNew molecular entity · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
