FDA Approval for GIVLAARI issued to ALNYLAM PHARMS INC
$ALNY
Biotechnology: Pharmaceutical Preparations
Health Care
New Drug Application (NDA): 212194
Company: ALNYLAM PHARMS INC
Company: ALNYLAM PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GIVLAARI | GIVOSIRAN SODIUM | EQ 189MG BASE/ML (EQ 189MG BASE/ML) | 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 |
|---|---|---|---|---|---|---|---|
| 11/20/2019 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/0212194s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/212194Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212194Orig1s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/29/2024 | SUPPL-7 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/212194Orig1s007ltr.pdf |
| 02/10/2023 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212194s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/212194Orig1s005ltr.pdf | |
| 10/28/2021 | SUPPL-4 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212194s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212194Orig1s004ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/10/2023 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212194s005lbl.pdf | |
| 10/28/2021 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212194s004lbl.pdf | |
| 11/20/2019 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/0212194s000lbl.pdf |