General MedicationsINJECTIONStandard
STRENSIQ
ASFOTASE ALFA
Standard Dose
80MG/0.8ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview STRENSIQ is listed in Drugs@FDA under application 125513 (BLA).
Review priority: STANDARD Marketing status: Prescription Active ingredient ASFOTASE ALFA Form and strength SOLUTION;INJECTION - 80MG/0.8ML Sponsor ALEXION PHARM Submission history Latest submission status date: 2024-07-10 00:00:00.
Structured Monograph
Clinical summary
Approval overview STRENSIQ is listed in Drugs@FDA under application 125513 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient ASFOTASE ALFA Form and strength SOLUTION;INJECTION - 80MG/0.8ML Sponsor ALEXION PHARM Submission history Latest submission status date: 2024-07-10 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.