Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 205552
Company: PHARMACYCLICS LLC
Company: PHARMACYCLICS LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| IMBRUVICA | IBRUTINIB | 140MG | CAPSULE;ORAL | Prescription | None | Yes | Yes |
| IMBRUVICA | IBRUTINIB | 70MG | CAPSULE;ORAL | Prescription | None | Yes | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 02/12/2014 | ORIG-2 | Approval | Efficacy | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205552Orig2lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205552Orig2s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205552Orig2s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205552Orig2s000SumR.pdf | |
| 11/13/2013 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) Review (PDF) Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/205552s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205552Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/205552Orig1S001.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/205552Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/18/2023 | SUPPL-40 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205552s040,210563s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/205552Orig1s040;210563Orig1s017ltr.pdf | |
| 08/24/2022 | SUPPL-38 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205552s038,210563s014lbl.pdf | |
| 08/24/2022 | SUPPL-37 | Efficacy-Labeling Change With Clinical Data |
Label is not available on this site. |
||
| 08/24/2022 | SUPPL-36 | Efficacy-New Patient Population |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205552s036,210563s012lbl.pdf | |
| 05/11/2022 | SUPPL-35 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205552s035,215063s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/205552Orig1s035; 215063Orig1s011ltr.pdf | |
| 12/22/2020 | SUPPL-33 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205552s033,210563s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/205552Orig1s033, 210563Orig1s010ltr.pdf | |
| 12/18/2020 | SUPPL-32 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205552s032,210563s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/205552Orig1s032; 210563Orig1s009ltr.pdf | |
| 08/07/2020 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205552s031,210563s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/205552Orig1s031,210563Orig1s007ltr.pdf | |
| 04/21/2020 | SUPPL-30 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205552s030,210563s006lblPI.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/205552Orig1s030,210563Orig1s006ltr.pdf | |
| 11/21/2019 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205552s029,210563s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/205552Orig1s029, 210563Orig1s004ltr.pdf | |
| 07/15/2019 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205552s028,210563s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/205552Orig1s028, 210563Orig1s003ltr.pdf | |
| 01/25/2019 | SUPPL-26 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205552s026,210563s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/205552Orig1s026,210563Orig1s002Ltr.pdf | |
| 08/24/2018 | SUPPL-25 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205552s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205552Orig1s025ltr.pdf | |
| 08/24/2018 | SUPPL-24 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205552s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205552Orig1s024,210563Orig1s001ltr.pdf | |
| 12/20/2017 | SUPPL-20 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205552s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205552Orig1s020ltr.pdf | |
| 08/02/2017 | SUPPL-17 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205552s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205552Orig1s017ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/205552Origs1s017.pdf https://www.accessdata.fda.gov/drugsatfda_docs/review/2018/205552Orig1s017SumR.pdf | |
| 01/18/2017 | SUPPL-16 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205552s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205552Orig1s016ltr.pdf | |
| 06/27/2016 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/06/2016 | SUPPL-13 | Efficacy-New Indication |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205552s010s013lbl.pdf | |
| 06/28/2016 | SUPPL-12 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205552Orig1s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205552Orig1s012ltr.pdf | |
| 04/13/2016 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/06/2016 | SUPPL-10 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205552s010s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205552Orig1s010,s013ltr.pdf | |
| 11/25/2015 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/08/2016 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/04/2016 | SUPPL-7 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205552s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205552Orig1s007ltr.pdf | |
| 03/21/2016 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/24/2015 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/17/2015 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/13/2015 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/29/2015 | SUPPL-2 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205552s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205552Orig1s002ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/205552Orig1s002.pdf | |
| 07/28/2014 | SUPPL-1 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205552s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205552Orig1s001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205552s001.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/18/2023 | SUPPL-40 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205552s040,210563s017lbl.pdf | |
| 08/24/2022 | SUPPL-38 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205552s038,210563s014lbl.pdf | |
| 08/24/2022 | SUPPL-36 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205552s036,210563s012lbl.pdf | |
| 05/11/2022 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205552s035,215063s011lbl.pdf | |
| 12/22/2020 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205552s033,210563s010lbl.pdf | |
| 12/18/2020 | SUPPL-32 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205552s032,210563s009lbl.pdf | |
| 08/07/2020 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205552s031,210563s007lbl.pdf | |
| 04/21/2020 | SUPPL-30 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205552s030,210563s006lblPI.pdf | |
| 11/21/2019 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205552s029,210563s004lbl.pdf | |
| 07/15/2019 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205552s028,210563s003lbl.pdf | |
| 01/25/2019 | SUPPL-26 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205552s026,210563s002lbl.pdf | |
| 08/24/2018 | SUPPL-25 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205552s025lbl.pdf | |
| 08/24/2018 | SUPPL-24 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205552s024lbl.pdf | |
| 12/20/2017 | SUPPL-20 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205552s020lbl.pdf | |
| 08/02/2017 | SUPPL-17 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205552s017lbl.pdf | |
| 01/18/2017 | SUPPL-16 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205552s016lbl.pdf | |
| 06/28/2016 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205552Orig1s012lbl.pdf | |
| 05/06/2016 | SUPPL-13 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205552s010s013lbl.pdf | |
| 05/06/2016 | SUPPL-10 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205552s010s013lbl.pdf | |
| 03/04/2016 | SUPPL-7 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205552s007lbl.pdf | |
| 01/29/2015 | SUPPL-2 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205552s002lbl.pdf | |
| 07/28/2014 | SUPPL-1 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205552s001lbl.pdf | |
| 02/12/2014 | ORIG-2 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205552Orig2lbl.pdf | |
| 11/13/2013 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/205552s000lbl.pdf |