Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 218730
Company: VERTEX PHARMS INC
Company: VERTEX PHARMS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ALYFTREK | DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM | 50MG;20MG;EQ 4MG BASE | TABLET;ORAL | Prescription | None | Yes | No |
ALYFTREK | DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM | 125MG;50MG;EQ 10MG BASE | 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 |
---|---|---|---|---|---|---|---|
12/20/2024 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218730s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/218730Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/218730Orig1s000TOC.cfm |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
12/20/2024 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218730s000lbl.pdf |