Treats metastatic colorectal cancer (mCRC). NDA 217564, held by Takeda Pharms USA. Fruquintinib.
As of Nov 14, 2026, NDA 217564 (Fruzaqla), held by Takeda Pharms USA, was first approved by FDA on Nov 8, 2023, with 1 approved supplement and 0 published complete response letters.
1. INDICATIONS AND USAGE FRUZAQLA is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine‑, oxaliplatin‑, and irinotecan‑based chemotherapy, an anti‑VEGF therapy, and, if RAS wild‑type and medically appropriate, an anti-EGFR therapy. FRUZAQLA is a kinase inhibitor
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 8, 2023 | Original applicationNew molecular entity · Priority review | Approved |
| Fruzaqla1MG · capsule;oral | Fruquintinib | RxReference drug |
| Fruzaqla5MG · capsule;oral | Fruquintinib | RxReference drug |
| Feb 28, 2025 | Supplement 2Labeling · Standard review | Approved | |
| Nov 8, 2023 | Original applicationNew molecular entity · Priority 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
