FDA Approval for TRYNGOLZA (AUTOINJECTOR) issued to IONIS PHARMS INC
$IONS
Biotechnology: Pharmaceutical Preparations
Health Care
New Drug Application (NDA): 218614
Company: IONIS PHARMS INC
Company: IONIS PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TRYNGOLZA (AUTOINJECTOR) | OLEZARSEN SODIUM | EQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML) | SOLUTION;SUBCUTANEOUS | 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 |
|---|---|---|---|---|---|---|---|
| 12/19/2024 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218614s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/218614Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/218614Orig1s000TOC.html |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/24/2026 | SUPPL-4 | Efficacy-New Indication |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/19/2024 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218614s000lbl.pdf |