FDA Approval for SUNLENCA issued to GILEAD SCIENCES INC
$GILD
Biotechnology: Biological Products (No Diagnostic Substances)
Health Care
New Drug Application (NDA): 215974
Company: GILEAD SCIENCES INC
Company: GILEAD SCIENCES INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SUNLENCA | LENACAPAVIR SODIUM | EQ 300MG 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 |
|---|---|---|---|---|---|---|---|
| 12/22/2022 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215974s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/215974Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/215973,215974Orig1s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/13/2024 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215974s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/215974Orig1s009ltr.pdf | |
| 11/25/2024 | SUPPL-8 | Efficacy-Labeling Change With Clinical Data |
Label is not available on this site. |
||
| 07/17/2024 | SUPPL-7 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215973s005,215974s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/215973Orig1s005,215974Orig1s007ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/13/2024 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215974s009lbl.pdf | |
| 07/17/2024 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215973s005,215974s007lbl.pdf | |
| 12/22/2022 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215974s000lbl.pdf |