FDA Approval for ORKAMBI issued to VERTEX PHARMS INC
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Biotechnology: Pharmaceutical Preparations
Health Care
New Drug Application (NDA): 211358
Company: VERTEX PHARMS INC
Company: VERTEX PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ORKAMBI | IVACAFTOR; LUMACAFTOR | 125MG/PACKET;100MG/PACKET | GRANULE;ORAL | Prescription | None | Yes | No |
| ORKAMBI | IVACAFTOR; LUMACAFTOR | 188MG/PACKET;150MG/PACKET | GRANULE;ORAL | Prescription | None | Yes | Yes |
| ORKAMBI | IVACAFTOR; LUMACAFTOR | 94MG/PACKET;75MG/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 |
|---|---|---|---|---|---|---|---|
| 08/07/2018 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211358s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/211358Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211358Orig1s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/03/2023 | SUPPL-5 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 09/02/2022 | SUPPL-4 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211358s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/211358Orig1s004ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/02/2022 | SUPPL-4 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211358s004lbl.pdf | |
| 08/07/2018 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211358s000lbl.pdf |