General MedicationsINJECTIONStandard
XTRENBO
DENOSUMAB-QBDE
Standard Dose
120MG/1.7ML(70MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview XTRENBO is listed in Drugs@FDA under application 761439 (BLA).
Review priority: STANDARD Marketing status: Prescription Active ingredient DENOSUMAB-QBDE Form and strength SOLUTION;INJECTION - 120MG/1.7ML(70MG/ML) Sponsor HIKMA PHARMACEUTICALS USA INC Submission history Latest submission status date: 2025-10-29 00:00:00.
Structured Monograph
Clinical summary
Approval overview XTRENBO is listed in Drugs@FDA under application 761439 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient DENOSUMAB-QBDE Form and strength SOLUTION;INJECTION - 120MG/1.7ML(70MG/ML) Sponsor HIKMA PHARMACEUTICALS USA INC Submission history Latest submission status date: 2025-10-29 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.