STN: BL 125596
Proper Name: Immune Globulin Subcutaneous (Human), 20% Solution
Manufacturer: Baxalta US, Inc.
- Indicated as replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients two years of age and older.
- September 13, 2016 Approval Letter - CUVITRU
The letter supersedes a previous version due to a redaction error.
- September 13, 2016 Summary Basis for Regulatory Action - CUVITRU
- Clinical Review - CUVITRU
- Statistical Review - CUVITRU
- Approval History, Letters, Reviews, and Related Documents - CUVITRU