General MedicationsINJECTIONStandard
CRYSVITA
BUROSUMAB-TWZA
Standard Dose
10MG/ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview CRYSVITA is listed in Drugs@FDA under application 761068 (BLA).
Review priority: STANDARD Marketing status: Prescription Active ingredient BUROSUMAB-TWZA Form and strength INJECTABLE;INJECTION - 10MG/ML Sponsor KYOWA KIRIN Submission history Latest submission status date: 2025-08-28 00:00:00.
Structured Monograph
Clinical summary
Approval overview CRYSVITA is listed in Drugs@FDA under application 761068 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient BUROSUMAB-TWZA Form and strength INJECTABLE;INJECTION - 10MG/ML Sponsor KYOWA KIRIN Submission history Latest submission status date: 2025-08-28 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.