Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 202714
Company: ONYX THERAP
Company: ONYX THERAP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| KYPROLIS | CARFILZOMIB | 60MG/VIAL | POWDER;INTRAVENOUS | Prescription | AP | Yes | Yes |
| KYPROLIS | CARFILZOMIB | 30MG/VIAL | POWDER;INTRAVENOUS | Prescription | None | Yes | No |
| KYPROLIS | CARFILZOMIB | 10MG/VIAL | POWDER;INTRAVENOUS | 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 |
|---|---|---|---|---|---|---|---|
| 07/20/2012 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD; Orphan |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202714lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202714Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202714Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202714Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/30/2022 | SUPPL-34 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/202714s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/202714Orig1s034ltr.pdf | |
| 11/30/2021 | SUPPL-33 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202714s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/202714Orig1s033ltr.pdf | |
| 03/09/2021 | SUPPL-32 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202714s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/202714Orig1s032ltr.pdf | |
| 08/20/2020 | SUPPL-30 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202714s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/202714Orig1s030ltr.pdf | |
| 05/07/2020 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202714s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/202714Orig1s029ltr.pdf | |
| 10/04/2019 | SUPPL-27 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202714s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/202714Orig1s027ltr.pdf | |
| 02/28/2019 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202714s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/202714Orig1s025ltr.pdf | |
| 09/28/2018 | SUPPL-21 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202714s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202714Orig1s021ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/202714Orig1s021TOC.cfm | |
| 06/07/2018 | SUPPL-19 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202714s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202714Orig1s019ltr.pdf | |
| 01/17/2018 | SUPPL-17 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202714s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202714Orig1s017ltr.pdf | |
| 05/25/2017 | SUPPL-16 | Labeling-Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202714s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202714Orig1s016ltr.pdf | |
| 11/17/2016 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202714s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202714Orig1s015ltr.pdf | |
| 11/21/2016 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/04/2016 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202714s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202714Orig1s013ltr.pdf | |
| 06/03/2016 | SUPPL-12 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202714s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202714s012ltr.pdf | |
| 05/23/2016 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202714s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202714Orig1s011ltr.pdf | |
| 01/21/2016 | SUPPL-10 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202714s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202714Orig1s010ltr.pdf | |
| 07/24/2015 | SUPPL-9 | Efficacy-Accelerated Approval |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202714s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202714Orig1s009ltr.pdf | |
| 03/27/2015 | SUPPL-8 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202714s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202714Orig1s008ltr.pdf | |
| 04/24/2015 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/21/2015 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/03/2014 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/02/2014 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/31/2014 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/19/2013 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/21/2013 | SUPPL-1 | 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 |
|---|---|---|---|---|---|
| 06/30/2022 | SUPPL-34 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/202714s034lbl.pdf | |
| 11/30/2021 | SUPPL-33 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202714s033lbl.pdf | |
| 03/09/2021 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202714s032lbl.pdf | |
| 08/20/2020 | SUPPL-30 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202714s030lbl.pdf | |
| 05/07/2020 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202714s029lbl.pdf | |
| 10/04/2019 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202714s027lbl.pdf | |
| 02/28/2019 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202714s025lbl.pdf | |
| 09/28/2018 | SUPPL-21 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202714s021lbl.pdf | |
| 06/07/2018 | SUPPL-19 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202714s019lbl.pdf | |
| 01/17/2018 | SUPPL-17 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202714s017lbl.pdf | |
| 05/25/2017 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202714s016lbl.pdf | |
| 05/25/2017 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202714s016lbl.pdf | |
| 11/17/2016 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202714s015lbl.pdf | |
| 08/04/2016 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202714s013lbl.pdf | |
| 06/03/2016 | SUPPL-12 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202714s012lbl.pdf | |
| 05/23/2016 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202714s011lbl.pdf | |
| 01/21/2016 | SUPPL-10 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202714s010lbl.pdf | |
| 07/24/2015 | SUPPL-9 | Efficacy-Accelerated Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202714s009lbl.pdf | |
| 03/27/2015 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202714s008lbl.pdf | |
| 07/20/2012 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202714lbl.pdf |
KYPROLIS
POWDER;INTRAVENOUS; 60MG/VIAL
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARFILZOMIB | CARFILZOMIB | 60MG/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 209422 | DR REDDYS |
| KYPROLIS | CARFILZOMIB | 60MG/VIAL | POWDER;INTRAVENOUS | Prescription | Yes | AP | 202714 | ONYX THERAP |