FDA Approval for TRIKAFTA (COPACKAGED) issued to VERTEX PHARMS INC
$VRTX
Biotechnology: Pharmaceutical Preparations
Health Care
New Drug Application (NDA): 212273
Company: VERTEX PHARMS INC
Company: VERTEX PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TRIKAFTA (COPACKAGED) | ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR | 100MG,75MG,50MG; 150MG | TABLET;ORAL | Prescription | None | Yes | Yes |
| TRIKAFTA (COPACKAGED) | ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR | 50MG,37.5MG,25MG; 75MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 10/21/2019 | ORIG-1 | Approval | Type 1 - New Molecular Entity and Type 4 - New Combination | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212273s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/212273Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/03/2023 | SUPPL-11 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 04/26/2023 | SUPPL-9 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212273s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/212273Orig1s009ltr.pdf | |
| 10/04/2021 | SUPPL-8 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212273s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212273Orig1s008ltr.pdf | |
| 06/08/2021 | SUPPL-4 | Efficacy-Manufacturing Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212273s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212273Orig1s004ltr.pdf | |
| 12/21/2020 | SUPPL-2 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212273s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/212273Orig1s002ltr.pdf | |
| 11/18/2020 | SUPPL-1 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212273s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/212273Orig1s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/26/2023 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212273s009lbl.pdf | |
| 04/26/2023 | SUPPL-9 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212273s009lbl.pdf | |
| 10/04/2021 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212273s008lbl.pdf | |
| 06/08/2021 | SUPPL-4 | Efficacy-Manufacturing Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212273s004lbl.pdf | |
| 12/21/2020 | SUPPL-2 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212273s002lbl.pdf | |
| 11/18/2020 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212273s001lbl.pdf | |
| 10/21/2019 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212273s000lbl.pdf |