Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 761032
Company: VALEANT LUXEMBOURG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SILIQ BRODALUMAB 210MG/1.5ML INJECTABLE;INJECTION 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
02/15/2017 ORIG-1 Approval N/A Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761032Orig1s000Ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761032Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/09/2018 SUPPL-5 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761032Orig1s005ltr.pdf
01/26/2018 SUPPL-4 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761032Orig1s004ltr.pdf
06/08/2017 SUPPL-1 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761032Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/15/2017 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761032lbl.pdf

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