Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761439
Company: HIKMA PHARMACEUTICALS USA INC

• Medication Guide

Products on BLA 761439

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ENOBY	DENOSUMAB-QBDE	60MG/ML	SOLUTION;INJECTION	Prescription	None	No	No
XTRENBO	DENOSUMAB-QBDE	120MG/1.7ML(70MG/ML)	SOLUTION;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761439

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/29/2025	ORIG-2	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761439s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761439Orig2s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2026/761439Orig2s000TOC.html
09/26/2025	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761439s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761439Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2026/761439Orig1s000TOC.html

Labels for BLA 761439

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/29/2025	ORIG-2	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761439s000lbl.pdf
09/26/2025	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761439s000lbl.pdf