Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 125349
Company: HUMAN GENOME SCIENCES INC.
Company: HUMAN GENOME SCIENCES INC.
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
RAXIBACUMAB | RAXIBACUMAB | 1700MG/34ML (50MG/ML) | INJECTABLE; IV (INFUSION) | 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 |
---|---|---|---|---|---|---|---|
12/14/2012 | ORIG-1 | Approval | N/A; Orphan |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125349s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125349Orig1s000ltr(r).pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/125349Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/125349Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/02/2021 | SUPPL-26 | Supplement |
Label (PDF)
Letter (PDF) Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125349s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125349Orig1s026ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125349Orig1s026ltr.pdf | |
01/11/2018 | SUPPL-22 | Supplement |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125349s022lbl.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
06/02/2021 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125349s026lbl.pdf | |
01/11/2018 | SUPPL-22 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125349s022lbl.pdf | |
12/14/2012 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125349s000lbl.pdf |