General MedicationsINJECTIONStandard
KRYSTEXXA
PEGLOTICASE
Standard Dose
8MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: PRIORITY Marketing status: Prescription
Summary
Approval overview KRYSTEXXA is listed in Drugs@FDA under application 125293 (BLA).
Review priority: PRIORITY Marketing status: Prescription Active ingredient PEGLOTICASE Form and strength INJECTABLE; INJECTION - 8MG Sponsor HORIZON PHARMA Submission history Latest submission status date: 2022-07-07 00:00:00.
Structured Monograph
Clinical summary
Approval overview KRYSTEXXA is listed in Drugs@FDA under application 125293 (BLA). Review priority: PRIORITY Marketing status: Prescription Active ingredient PEGLOTICASE Form and strength INJECTABLE; INJECTION - 8MG Sponsor HORIZON PHARMA Submission history Latest submission status date: 2022-07-07 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: PRIORITY
Interaction Notes
- No interaction notes stored yet.