Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 203469
Company: TAKEDA PHARMS USA
Company: TAKEDA PHARMS USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ICLUSIG | PONATINIB HYDROCHLORIDE | EQ 15MG BASE | TABLET;ORAL | Prescription | None | Yes | No |
| ICLUSIG | PONATINIB HYDROCHLORIDE | EQ 45MG BASE | TABLET;ORAL | Prescription | None | Yes | Yes |
| ICLUSIG | PONATINIB HYDROCHLORIDE | EQ 30MG BASE | TABLET;ORAL | Prescription | None | Yes | No |
| ICLUSIG | PONATINIB HYDROCHLORIDE | EQ 10MG BASE | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 12/14/2012 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203469lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203469Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203469Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203469Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/19/2024 | SUPPL-37 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/203469s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/203469Orig1s037ltr.pdf | |
| 02/15/2022 | SUPPL-35 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/203469s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/203469Orig1s035ltr.pdf | |
| 12/18/2020 | SUPPL-34 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203469s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/203469Orig1s034ltr.pdf | |
| 07/10/2020 | SUPPL-33 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203469s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/203469Orig1s033ltr.pdf | |
| 06/17/2020 | SUPPL-32 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203469s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/203469Orig1s032ltr.pdf | |
| 01/10/2020 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203469s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/203469Orig1s031ltr.pdf | |
| 10/18/2018 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203469s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203469Orig1s030ltr.pdf | |
| 05/29/2018 | SUPPL-29 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203469Orig1s029ltr.pdf |
| 12/20/2017 | SUPPL-28 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203469s027s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203469Orig1s027,s028ltr.pdf | |
| 12/20/2017 | SUPPL-27 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203469s027s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203469Orig1s027,s028ltr.pdf | |
| 09/07/2016 | SUPPL-24 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203469s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203469Orig1s024ltr.pdf | |
| 08/31/2016 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203469s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203469Orig1s023ltr.pdf | |
| 11/28/2016 | SUPPL-22 | Efficacy-Accelerated Approval |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203469s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203469Orig1s022ltr.pdf | |
| 06/02/2016 | SUPPL-21 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203469s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203469Orig1s021ltr.pdf | |
| 12/02/2015 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203469s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203469Orig1s020ltr.pdf | |
| 12/01/2015 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/24/2015 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/23/2015 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/17/2015 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/20/2015 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/03/2015 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/20/2015 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/09/2014 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/15/2014 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/30/2014 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/24/2014 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203469s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203469Orig1s009ltr.pdf | |
| 12/20/2013 | SUPPL-8 | REMS-Proposal |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203469s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203469Orig1s007,s008ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203469Orig1s007,s008.pdf | |
| 12/20/2013 | SUPPL-7 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203469s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203469Orig1s007,s008ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203469Orig1s007,s008.pdf | |
| 03/27/2014 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/30/2014 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/12/2013 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/25/2013 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/19/2024 | SUPPL-37 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/203469s037lbl.pdf | |
| 02/15/2022 | SUPPL-35 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/203469s035lbl.pdf | |
| 12/18/2020 | SUPPL-34 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203469s034lbl.pdf | |
| 07/10/2020 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203469s033lbl.pdf | |
| 06/17/2020 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203469s032lbl.pdf | |
| 01/10/2020 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203469s031lbl.pdf | |
| 10/18/2018 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203469s030lbl.pdf | |
| 12/20/2017 | SUPPL-28 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203469s027s028lbl.pdf | |
| 12/20/2017 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203469s027s028lbl.pdf | |
| 12/20/2017 | SUPPL-27 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203469s027s028lbl.pdf | |
| 12/20/2017 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203469s027s028lbl.pdf | |
| 11/28/2016 | SUPPL-22 | Efficacy-Accelerated Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203469s022lbl.pdf | |
| 09/07/2016 | SUPPL-24 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203469s024lbl.pdf | |
| 08/31/2016 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203469s023lbl.pdf | |
| 06/02/2016 | SUPPL-21 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203469s021lbl.pdf | |
| 12/02/2015 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203469s020lbl.pdf | |
| 07/24/2014 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203469s009lbl.pdf | |
| 12/20/2013 | SUPPL-8 | REMS-Proposal | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203469s007s008lbl.pdf | |
| 12/20/2013 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203469s007s008lbl.pdf | |
| 12/14/2012 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203469lbl.pdf |