FDA Approval for JAKAFI issued to INCYTE CORP
$INCY
Biotechnology: Commercial Physical & Biological Resarch
Health Care
New Drug Application (NDA): 202192
Company: INCYTE CORP
Company: INCYTE CORP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| JAKAFI | RUXOLITINIB PHOSPHATE | EQ 5MG BASE | TABLET;ORAL | Prescription | None | Yes | No |
| JAKAFI | RUXOLITINIB PHOSPHATE | EQ 10MG BASE | TABLET;ORAL | Prescription | None | Yes | No |
| JAKAFI | RUXOLITINIB PHOSPHATE | EQ 15MG BASE | TABLET;ORAL | Prescription | None | Yes | No |
| JAKAFI | RUXOLITINIB PHOSPHATE | EQ 20MG BASE | TABLET;ORAL | Prescription | None | Yes | No |
| JAKAFI | RUXOLITINIB PHOSPHATE | EQ 25MG BASE | TABLET;ORAL | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 11/16/2011 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202192lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202192s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202192Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202192Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/22/2021 | SUPPL-23 | Efficacy-New Indication |
Label is not available on this site. |
||
| 01/14/2020 | SUPPL-19 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202192Orig1s019Rpllbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/202192Orig1s019ltr.pdf | |
| 05/24/2019 | SUPPL-17 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202192s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/202192Orig1s017ltr.pdf | |
| 10/26/2018 | SUPPL-16 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202192s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202192Orig1s016ltr.pdf | |
| 12/06/2017 | SUPPL-15 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202192s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202192Orig1s015ltr.pdf | |
| 10/10/2017 | SUPPL-14 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202192s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202192Orig1s014ltr.pdf | |
| 03/10/2016 | SUPPL-12 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202192s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202192Orig1s012ltr.pdf | |
| 10/06/2015 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/02/2015 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/15/2014 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202192s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202192Orig1s009ltr.pdf | |
| 12/04/2014 | SUPPL-8 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202192s008lblPi.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202192Orig1s008ltr.pdf | |
| 05/30/2014 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/25/2014 | SUPPL-6 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202192s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202192Orig1s006ltr.pdf | |
| 11/25/2013 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202192s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202192Orig1s005ltr.pdf | |
| 11/07/2013 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/12/2013 | SUPPL-3 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202192s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202192Orig1s003ltr.pdf | |
| 06/21/2012 | SUPPL-1 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202192s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202192s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/14/2020 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202192Orig1s019Rpllbl.pdf | |
| 05/24/2019 | SUPPL-17 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202192s017lbl.pdf | |
| 10/26/2018 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202192s016lbl.pdf | |
| 12/06/2017 | SUPPL-15 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202192s015lbl.pdf | |
| 12/06/2017 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202192s015lbl.pdf | |
| 10/10/2017 | SUPPL-14 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202192s014lbl.pdf | |
| 03/10/2016 | SUPPL-12 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202192s012lbl.pdf | |
| 12/15/2014 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202192s009lbl.pdf | |
| 12/04/2014 | SUPPL-8 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202192s008lblPi.pdf | |
| 07/25/2014 | SUPPL-6 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202192s006lbl.pdf | |
| 11/25/2013 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202192s005lbl.pdf | |
| 06/12/2013 | SUPPL-3 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202192s003lbl.pdf | |
| 06/21/2012 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202192s001lbl.pdf | |
| 11/16/2011 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202192lbl.pdf |