Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 202570
Company: PF PRISM CV
Company: PF PRISM CV
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| XALKORI | CRIZOTINIB | 200MG | CAPSULE;ORAL | Prescription | None | Yes | No |
| XALKORI | CRIZOTINIB | 250MG | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 08/26/2011 | 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/2011/202570s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202570Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202570Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202570Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/07/2023 | SUPPL-36 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202570s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/202570Orig1s036ltr.pdf | |
| 07/14/2022 | SUPPL-33 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/202570s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/202570Orig1s033ltr.pdf | |
| 09/22/2021 | SUPPL-31 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202570s031lbl.pdf | |
| 01/14/2021 | SUPPL-30 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202570s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/202570Orig1s030ltr.pdf | |
| 06/25/2019 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202570s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/202570Orig1s028ltr.pdf | |
| 12/06/2018 | SUPPL-27 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202570s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202570s027ltr.pdf | |
| 11/30/2018 | SUPPL-26 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202570s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202570s026ltr.pdf | |
| 02/07/2018 | SUPPL-24 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202570Orig1s024ltr.pdf |
| 02/07/2018 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202570s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202570Orig1s023ltr.pdf | |
| 07/21/2017 | SUPPL-21 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202570s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202570Orig1s021ltr.pdf | |
| 01/24/2017 | SUPPL-20 | Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202570s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202570Orig1s020ltr.pdf | |
| 04/28/2017 | SUPPL-19 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202570s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202570Orig1s019ltr.pdf | |
| 04/28/2016 | SUPPL-18 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202570s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202570Orig1s018ltr.pdf | |
| 04/29/2016 | SUPPL-17 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202570s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202570Orig1s017ltr.pdf | |
| 03/11/2016 | SUPPL-16 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202570s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202570Orig1s016ltr.pdf | |
| 12/07/2015 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/14/2015 | SUPPL-14 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202570s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202570Orig1s014ltr.pdf | |
| 03/20/2015 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202570s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202570Orig1s013ltr.pdf | |
| 08/26/2014 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/28/2014 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202570s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202570Orig1s011ltr.pdf | |
| 02/14/2014 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/07/2013 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202570s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202570Orig1s007,s009ltr.pdf | |
| 09/13/2013 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/07/2013 | SUPPL-7 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202570s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202570s007,s009ltr.pdf | |
| 11/20/2013 | SUPPL-6 | Efficacy-Accelerated Approval |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202570s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202570Orig1s006ltr.pdf | |
| 03/12/2013 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/28/2013 | SUPPL-4 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202570s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202570Orig1s004ltr.pdf | |
| 02/24/2012 | SUPPL-3 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202570s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202570s003ltr.pdf | |
| 02/17/2012 | SUPPL-2 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202570s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202570s002ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/07/2023 | SUPPL-36 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202570s036lbl.pdf | |
| 07/14/2022 | SUPPL-33 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/202570s033lbl.pdf | |
| 09/22/2021 | SUPPL-31 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202570s031lbl.pdf | |
| 09/22/2021 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202570s031lbl.pdf | |
| 01/14/2021 | SUPPL-30 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202570s030lbl.pdf | |
| 06/25/2019 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202570s028lbl.pdf | |
| 12/06/2018 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202570s027lbl.pdf | |
| 11/30/2018 | SUPPL-26 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202570s026lbl.pdf | |
| 02/07/2018 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202570s023lbl.pdf | |
| 07/21/2017 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202570s021lbl.pdf | |
| 04/28/2017 | SUPPL-19 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202570s019lbl.pdf | |
| 01/24/2017 | SUPPL-20 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202570s020lbl.pdf | |
| 04/29/2016 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202570s017lbl.pdf | |
| 04/28/2016 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202570s018lbl.pdf | |
| 03/11/2016 | SUPPL-16 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202570s016lbl.pdf | |
| 09/14/2015 | SUPPL-14 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202570s014lbl.pdf | |
| 03/20/2015 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202570s013lbl.pdf | |
| 05/28/2014 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202570s011lbl.pdf | |
| 11/20/2013 | SUPPL-6 | Efficacy-Accelerated Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202570s006lbl.pdf | |
| 10/07/2013 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202570s009lbl.pdf | |
| 10/07/2013 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202570s007lbl.pdf | |
| 02/28/2013 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202570s004lbl.pdf | |
| 02/24/2012 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202570s003lbl.pdf | |
| 02/17/2012 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202570s002lbl.pdf | |
| 08/26/2011 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202570s000lbl.pdf |