FDA Approval for TRODELVY issued to IMMUNOMEDICS INC
$IMMU
Biotechnology: In Vitro & In Vivo Diagnostic Substances
Health Care
Biologic License Application (BLA): 761115
Company: IMMUNOMEDICS INC
Company: IMMUNOMEDICS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TRODELVY | SACITUZUMAB GOVITECAN-HZIY | 180MG | INJECTABLE;INJECTION | Prescription | None | TBD | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 04/22/2020 | ORIG-1 | Approval | N/A |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761115s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761115Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761115Orig1s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/03/2023 | SUPPL-35 | Supplement |
Label is not available on this site. |
||
| 06/30/2022 | SUPPL-31 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761115Orig1s031Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761115Orig1s031ltr.pdf | |
| 06/03/2022 | SUPPL-23 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761115s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761115Orig1s023ltr.pdf | |
| 04/07/2021 | SUPPL-13 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761115s005s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761115Orig1s005, s013ltr.pdf | |
| 04/13/2021 | SUPPL-9 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761115s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761115Orig1s009ltr.pdf | |
| 04/07/2021 | SUPPL-5 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761115s005s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761115Orig1s005, s013ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/30/2022 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761115Orig1s031Lbl.pdf | |
| 06/03/2022 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761115s023lbl.pdf | |
| 04/13/2021 | SUPPL-9 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761115s009lbl.pdf | |
| 04/07/2021 | SUPPL-13 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761115s005s013lbl.pdf | |
| 04/07/2021 | SUPPL-5 | Efficacy-Accelerated Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761115s005s013lbl.pdf | |
| 04/22/2020 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761115s000lbl.pdf |