FDA Approval for REBLOZYL issued to CELGENE CORP
$CELG~
Biologic License Application (BLA): 761136
Company: CELGENE CORP
Company: CELGENE CORP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| REBLOZYL | LUSPATERCEPT-AAMT | 25MG/VIAL | POWDER;SUBCUTANEOUS | Prescription | None | No | No |
| REBLOZYL | LUSPATERCEPT-AAMT | 75MG/VIAL | POWDER;SUBCUTANEOUS | Prescription | None | No | 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 |
|---|---|---|---|---|---|---|---|
| 04/03/2020 | ORIG-2 | Approval | N/A; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761136orig2lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761136Orig2s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761136Orig2s000TOC.cfm | ||
| 11/08/2019 | ORIG-1 | Approval | N/A; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761136lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761136Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761136Orig1s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/16/2024 | SUPPL-10 | Supplement |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761136s010lbl.pdf | |
| 08/28/2023 | SUPPL-9 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761136s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761136Orig1s009ltr.pdf | |
| 07/08/2022 | SUPPL-6 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761136s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761136Orig1s006ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/16/2024 | SUPPL-10 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761136s010lbl.pdf | |
| 08/28/2023 | SUPPL-9 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761136s009lbl.pdf | |
| 07/08/2022 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761136s006lbl.pdf | |
| 07/08/2022 | SUPPL-6 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761136s006lbl.pdf | |
| 04/03/2020 | ORIG-2 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761136orig2lbl.pdf | |
| 11/08/2019 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761136lbl.pdf |