FDA Approval for KALYDECO issued to VERTEX PHARMS INC
$VRTX
Biotechnology: Pharmaceutical Preparations
Health Care
New Drug Application (NDA): 207925
Company: VERTEX PHARMS INC
Company: VERTEX PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| KALYDECO | IVACAFTOR | 50MG/PACKET | GRANULE;ORAL | Prescription | None | Yes | No |
| KALYDECO | IVACAFTOR | 75MG/PACKET | GRANULE;ORAL | Prescription | None | Yes | Yes |
| KALYDECO | IVACAFTOR | 25MG/PACKET | GRANULE;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 |
|---|---|---|---|---|---|---|---|
| 03/17/2015 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207925s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207925Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207925Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207925Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/03/2023 | SUPPL-16 |
Label is not available on this site. |
|||
| 12/21/2020 | SUPPL-13 | 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-11 | 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-8 | Efficacy-Labeling Change With Clinical Data |
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-7 | 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-5 | 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 | |
| 02/08/2017 | SUPPL-3 | 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 | |
| 06/08/2016 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/17/2017 | SUPPL-1 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207925s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203188Orig1s019,207925Orig1s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/21/2020 | SUPPL-13 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203188s034,207925s013lbl.pdf | |
| 09/24/2020 | SUPPL-11 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203188s033,207925s011lbl.pdf | |
| 04/29/2019 | SUPPL-8 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203188s029,207925s008lbl.pdf | |
| 08/15/2018 | SUPPL-7 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203188s028,207925s007lbl.pdf | |
| 07/31/2017 | SUPPL-5 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203188s026,207925s005lbl.pdf | |
| 05/17/2017 | SUPPL-1 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207925s001lbl.pdf | |
| 02/08/2017 | SUPPL-3 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203188s022l_207925s003lbl.pdf | |
| 03/17/2015 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207925s000lbl.pdf |