Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 761083
Company: GENENTECH INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HEMLIBRA EMICIZUMAB 30MG/ML INJECTABLE;INJECTION Prescription None TBD No
HEMLIBRA EMICIZUMAB 60MG/0.4ML INJECTABLE;INJECTION Prescription None TBD No
HEMLIBRA EMICIZUMAB 105MG/0.7ML INJECTABLE;INJECTION Prescription None TBD No
HEMLIBRA EMICIZUMAB 150MG 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
11/16/2017 ORIG-1 Approval N/A; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761083s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761083Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761083Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/04/2018 SUPPL-4 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761083s002s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761083Orig1s002,761083Orig1s004Ltr.pdf
10/04/2018 SUPPL-2 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761083s002s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761083Orig1s002,761083Orig1s004Ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/04/2018 SUPPL-4 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761083s002s004lbl.pdf
10/04/2018 SUPPL-2 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761083s002s004lbl.pdf
11/16/2017 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761083s000lbl.pdf

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