NDA 212904, held by Aveo Pharms. Tivozanib Hydrochloride.
As of Nov 14, 2026, NDA 212904 (Fotivda), held by Aveo Pharms, was first approved by FDA on Mar 10, 2021, with 2 approved supplements and 0 published complete response letters.
FOTIVDA is indicated for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 10, 2021 | Original applicationNew molecular entity · Standard review | Approved |
| FotivdaEQ 0.89MG BASE · capsule;oral | Tivozanib Hydrochloride | RxReference drug |
| FotivdaEQ 1.34MG BASE · capsule;oral | Tivozanib Hydrochloride | RxReference drug |
| Jan 30, 2025 | Supplement 3Labeling · Standard review | Approved | |
| Aug 6, 2024 | Supplement 2Labeling · Standard review | Approved | |
| Mar 10, 2021 | 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
