Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 203188
Company: VERTEX PHARMS
Company: VERTEX PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| KALYDECO | IVACAFTOR | 150MG | 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 |
|---|---|---|---|---|---|---|---|
| 01/31/2012 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203188lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203188s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203188s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/03/2023 | SUPPL-40 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/203188s040,207925s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/203188Orig1s040;207925Orig1s017ltr.pdf | |
| 05/03/2023 | SUPPL-38 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/203188s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/203188Orig1s038ltr.pdf | |
| 12/21/2020 | SUPPL-34 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203188s034,207925s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/203188Orig1s034, 207925Orig1s013ltr.pdf | |
| 09/24/2020 | SUPPL-33 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203188s033,207925s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/207925Orig1s011;203188Orig1s033ltr.pdf | |
| 04/29/2019 | SUPPL-29 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203188s029,207925s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/203188Orig1s029, 20795Orig1s008ltr.pdf | |
| 08/15/2018 | SUPPL-28 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203188s028,207925s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203188Orig1s028,207925Orig1s007ltr.pdf | |
| 07/31/2017 | SUPPL-26 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203188s026,207925s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203188Orig1s026,207925Orig1s005ltr.pdf | |
| 01/11/2017 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/08/2017 | SUPPL-22 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203188s022l_207925s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203188Orig1s022,207925Orig1s003ltr.pdf | |
| 05/20/2016 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/17/2017 | SUPPL-19 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203188s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203188Orig1s019,207925Orig1s001ltr.pdf | |
| 09/01/2015 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/04/2015 | SUPPL-17 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203188s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203188Orig1s017ltr.pdf | |
| 01/05/2015 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/29/2014 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203188s014s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203188Orig1s014,s015ltr.pdf | |
| 12/29/2014 | SUPPL-14 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203188s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203188Orig1s014,s015ltr.pdf | |
| 12/11/2014 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/10/2014 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/29/2014 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/09/2015 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/24/2015 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/08/2014 | SUPPL-8 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203188s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203188Orig1s008ltr.pdf | |
| 06/13/2014 | SUPPL-7 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203188s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203188Orig1s007ltr.pdf | |
| 02/21/2014 | SUPPL-4 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203188s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203188Orig1s004ltr.pdf | |
| 12/13/2013 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/03/2013 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/28/2012 | SUPPL-1 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203188s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203188Orig1s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/03/2023 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/203188s040,207925s017lbl.pdf | |
| 05/03/2023 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/203188s038lbl.pdf | |
| 05/03/2023 | SUPPL-38 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/203188s038lbl.pdf | |
| 12/21/2020 | SUPPL-34 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203188s034,207925s013lbl.pdf | |
| 09/24/2020 | SUPPL-33 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203188s033,207925s011lbl.pdf | |
| 04/29/2019 | SUPPL-29 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203188s029,207925s008lbl.pdf | |
| 08/15/2018 | SUPPL-28 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203188s028,207925s007lbl.pdf | |
| 07/31/2017 | SUPPL-26 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203188s026,207925s005lbl.pdf | |
| 05/17/2017 | SUPPL-19 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203188s019lbl.pdf | |
| 02/08/2017 | SUPPL-22 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203188s022l_207925s003lbl.pdf | |
| 03/04/2015 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203188s017lbl.pdf | |
| 12/29/2014 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203188s014s015lbl.pdf | |
| 12/29/2014 | SUPPL-14 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203188s014lbl.pdf | |
| 06/13/2014 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203188s007lbl.pdf | |
| 04/08/2014 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203188s008lbl.pdf | |
| 02/21/2014 | SUPPL-4 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203188s004lbl.pdf | |
| 08/28/2012 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203188s001lbl.pdf | |
| 01/31/2012 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203188lbl.pdf |