Treats chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). NDA 205552, held by Pharmacyclics LLC. Ibrutinib.
As of Nov 14, 2026, NDA 205552 (Imbruvica), held by Pharmacyclics LLC, was first approved by FDA on Feb 12, 2014, with 35 approved supplements and 0 published complete response letters.
IMBRUVICA is a kinase inhibitor indicated for the treatment of: Adult patients with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL). Adult patients with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion. Adult patients with Waldenström’s macroglobulinemia (WM). Adult and pediatric patients age 1 year and older with chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy. 1.1 Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma IMBRUVICA is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). 1.
| May 18, 2023 | Supplement 40Efficacy (new indication or use) · Standard review | Approved | |
| Aug 24, 2022 | Supplement 38Efficacy (new indication or use) · Priority review | Approved | |
| Aug 24, 2022 | Supplement 37Efficacy (new indication or use) · Standard review | Approved | None posted |
| Aug 24, 2022 | Supplement 36Efficacy (new indication or use) · Priority review | Approved | |
| Dec 18, 2020 | Supplement 32Efficacy (new indication or use) · Standard review | Approved | |
| Apr 21, 2020 | Supplement 30Efficacy (new indication or use) · Priority review | Approved | |
| Jan 25, 2019 | Supplement 26Efficacy (new indication or use) · Priority review | Approved | |
| Aug 24, 2018 | Supplement 24Efficacy (new indication or use) · Priority review | Approved | |
| Dec 20, 2017 | Supplement 20Efficacy (new indication or use) · Priority review | Approved | |
| Aug 2, 2017 | Supplement 17Efficacy (new indication or use) · Priority review | Approved | |
| Jan 18, 2017 | Supplement 16Efficacy (new indication or use) · Priority review | Approved | |
| May 6, 2016 | Supplement 13Efficacy (new indication or use) · Priority review | Approved | |
| May 6, 2016 | Supplement 10Efficacy (new indication or use) · Priority review | Approved | |
| Mar 4, 2016 | Supplement 7Efficacy (new indication or use) · Priority review | Approved | |
| Jan 29, 2015 | Supplement 2Efficacy (new indication or use) · Priority review | Approved | |
| Jul 28, 2014 | Supplement 1Efficacy (new indication or use) · Priority review | Approved | |
| Feb 12, 2014 | Original applicationEfficacy (new indication or use) · Priority review | Approved | |
| Nov 13, 2013 | Original applicationNew molecular entity · Priority review | Approved |
| Oct 21, 2025 | Supplement 44Labeling · Standard review | Approved | |
| Dec 20, 2024 | Supplement 43Labeling · Standard review | Approved | |
| May 9, 2024 | Supplement 42Labeling | Approved | |
| May 18, 2023 | Supplement 40Efficacy (new indication or use) · Standard review | Approved | |
| Aug 24, 2022 | Supplement 38Efficacy (new indication or use) · Priority review | Approved | |
| Aug 24, 2022 | Supplement 37Efficacy (new indication or use) · Standard review | Approved | None posted |
| Aug 24, 2022 | Supplement 36Efficacy (new indication or use) · Priority review | Approved | |
| May 11, 2022 | Supplement 35Labeling · Standard review | Approved | |
| Dec 22, 2020 | Supplement 33Labeling · Standard review | Approved | |
| Dec 18, 2020 | Supplement 32Efficacy (new indication or use) · Standard review | Approved | |
| Aug 7, 2020 | Supplement 31Labeling · Standard review | Approved | |
| Apr 21, 2020 | Supplement 30Efficacy (new indication or use) · Priority review | Approved | |
| Nov 21, 2019 | Supplement 29Labeling · Standard review | Approved | |
| Jul 15, 2019 | Supplement 28Labeling · Standard review | Approved | |
| Jan 25, 2019 | Supplement 26Efficacy (new indication or use) · Priority review | Approved | |
| Aug 24, 2018 | Supplement 25Labeling · Standard review | Approved | |
| Aug 24, 2018 | Supplement 24Efficacy (new indication or use) · Priority review | Approved | |
| Dec 20, 2017 | Supplement 20Efficacy (new indication or use) · Priority review | Approved | |
| Aug 2, 2017 | Supplement 17Efficacy (new indication or use) · Priority review | Approved | |
| Jul 10, 2017 | Supplement 18Manufacturing | Approved | |
| Jan 18, 2017 | Supplement 16Efficacy (new indication or use) · Priority review | Approved | |
| Jun 28, 2016 | Supplement 12Labeling · Standard review | Approved | |
| Jun 27, 2016 | Supplement 14Manufacturing · Priority review | Approved | None posted |
| May 6, 2016 | Supplement 13Efficacy (new indication or use) · Priority review | Approved | |
| May 6, 2016 | Supplement 10Efficacy (new indication or use) · Priority review | Approved | |
| Apr 13, 2016 | Supplement 11Manufacturing · Priority review | Approved | None posted |
| Mar 21, 2016 | Supplement 6Manufacturing · Priority review | Approved | None posted |
| Mar 4, 2016 | Supplement 7Efficacy (new indication or use) · Priority review | Approved | |
| Feb 8, 2016 | Supplement 8Manufacturing · Priority review | Approved | None posted |
| Nov 25, 2015 | Supplement 9Manufacturing · Priority review | Approved | None posted |
| Aug 24, 2015 | Supplement 5Manufacturing · Priority review | Approved | None posted |
| Aug 17, 2015 | Supplement 4Manufacturing · Priority review | Approved | None posted |
| Aug 13, 2015 | Supplement 3Manufacturing · Priority review | Approved | |
| Jan 29, 2015 | Supplement 2Efficacy (new indication or use) · Priority review | Approved | |
| Jul 28, 2014 | Supplement 1Efficacy (new indication or use) · Priority review | Approved | |
| Feb 12, 2014 | Original applicationEfficacy (new indication or use) · Priority review | Approved | |
| Nov 13, 2013 | 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
