General MedicationsSUBCUTANEOUSStandard
OSVYRTI
denosumab-desu
Standard Dose
60MG/ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview OSVYRTI is listed in Drugs@FDA under application 761424 (BLA).
Review priority: STANDARD Marketing status: Prescription Active ingredient denosumab-desu Form and strength INJECTABLE;SUBCUTANEOUS - 60MG/ML Sponsor ACCORD BIOPHARMA INC.
Structured Monograph
Clinical summary
Approval overview OSVYRTI is listed in Drugs@FDA under application 761424 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient denosumab-desu Form and strength INJECTABLE;SUBCUTANEOUS - 60MG/ML Sponsor ACCORD BIOPHARMA 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.