FDA Approval for OXLUMO issued to ALNYLAM PHARMS INC
$ALNY
Biotechnology: Pharmaceutical Preparations
Health Care
New Drug Application (NDA): 214103
Company: ALNYLAM PHARMS INC
Company: ALNYLAM PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| OXLUMO | LUMASIRAN SODIUM | EQ 94.5MG BASE/0.5ML (EQ 94.5MG BASE/0.5ML) | 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 |
|---|---|---|---|---|---|---|---|
| 11/23/2020 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/214103lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/214103Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/214103Orig1s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/19/2023 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/06/2022 | SUPPL-3 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214103s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214103Orig1s003ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/06/2022 | SUPPL-3 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214103s003lbl.pdf | |
| 11/23/2020 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/214103lbl.pdf |