Treats multiple myeloma. NDA 208462, held by Takeda Pharms USA. Ixazomib Citrate.
As of Nov 14, 2026, NDA 208462 (Ninlaro), held by Takeda Pharms USA, was first approved by FDA on Nov 20, 2015, with 9 approved supplements and 0 published complete response letters.
NINLARO is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.
| Apr 28, 2022 | Supplement 12Efficacy (new indication or use) · Standard review | Approved | |
| Nov 20, 2015 | Original applicationNew molecular entity · Priority review | Approved |
| NinlaroEQ 2.3MG BASE · capsule;oral | Ixazomib Citrate | RxReference drug |
| NinlaroEQ 3MG BASE · capsule;oral | Ixazomib Citrate | RxReference drug |
| NinlaroEQ 4MG BASE · capsule;oral | Ixazomib Citrate | RxReference drug |
| Jul 1, 2024 | Supplement 17Labeling · Standard review | Approved | |
| Mar 1, 2024 | Supplement 16Labeling · Standard review | Approved | |
| Apr 28, 2022 | Supplement 13Labeling · Standard review | Approved | |
| Apr 28, 2022 | Supplement 12Efficacy (new indication or use) · Standard review | Approved | |
| Mar 10, 2021 | Supplement 10Labeling · Standard review | Approved | |
| Sep 10, 2020 | Supplement 8Labeling · Standard review | Approved | |
| Sep 10, 2020 | Supplement 7Labeling · Standard review | Approved | |
| Feb 21, 2020 | Supplement 6Labeling · Standard review | Approved | |
| Nov 23, 2016 | Supplement 1Labeling · Standard review | Approved | |
| Nov 20, 2015 | 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
