Treats newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+…. NDA 218922, held by Cipla. Nilotinib D-Tartrate.
As of Nov 13, 2026, NDA 218922 (Nilotinib D-Tartrate), held by Cipla, was first approved by FDA on Feb 19, 2025, with 1 approved supplement and 0 published complete response letters.
Nilotinib Capsules is a kinase inhibitor indicated for the treatment of: Adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. Adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib. 1.1 Adult Patients With Newly Diagnosed Ph+ CML-CP Nilotinib Capsules is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. Additional pediatric use information is approved for Novartis Pharmaceuticals Corporation’s Tasigna (nilotinib) capsules.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 19, 2025 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Nilotinib D-TartrateEQ 50MG BASE · capsule;oral | Nilotinib D-Tartrate | DiscontinuedReference drug |
| Nilotinib D-TartrateEQ 150MG BASE · capsule;oral | Nilotinib D-Tartrate | DiscontinuedReference drug |
| Nilotinib D-TartrateEQ 200MG BASE · capsule;oral | Nilotinib D-Tartrate | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 10, 2025 | Supplement 1Labeling · Standard review | Approved | |
| Feb 19, 2025 | 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
