NDA 219097, held by Shorla Oncology. Imatinib Mesylate.
As of Nov 13, 2026, NDA 219097 (Imkeldi), held by Shorla Oncology, was first approved by FDA on Nov 22, 2024, with 1 approved supplement and 0 published complete response letters.
IMKELDI is a kinase inhibitor indicated for the treatment of: Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. Patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy. Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). Pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 22, 2024 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| ImkeldiEQ 80MG BASE/ML · solution;oral | Imatinib Mesylate | RxReference drug |
| Oct 16, 2026 | Supplement 4Labeling · Standard review | Approved | |
| Nov 22, 2024 | Original applicationNew dosage form · 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
