STN #: BLA 125668
Proper Name: Immune Globulin Subcutaneous (Human) -hipp, 16.5%
Manufacturer: OCTAPHARMA Pharmazeutika Produktionsges.m.b.H.
- CUTAQUIG (Immune Globulin Subcutaneous (Human) - hipp) is a 16.5% immune globulin solution for subcutaneous infusion indicated for treatment of primary humoral immunodeficiency (PI) in adults and Pediatric patients 2 years of age and older.
- Package Insert - CUTAQUIG
- Demographic Subgroup Information – Immune Globulin Subcutaneous (Human)
Refer to Section 1.1 of the clinical reviewer memo for information about participation in the clinical trials and any analysis of demographic subgroup outcomes that is notable.
- October 22, 2021, Approval Letter - CUTAQUIG
- May 14, 2020 Approval Letter - CUTAQUIG
- December 12, 2018 Approval Letter - CUTAQUIG
- December 12, 2018 Summary Basis for Regulatory Action - CUTAQUIG
- Clinical Review - CUTAQUIG
- Statistical Review - CUTAQUIG
- Approval History, Letters, Reviews, and Related Documents - CUTAQUIG
- Expiration Date Extension for 43 Cutaquig [Immune globulin, Subcutaneous (Human)-hipp, 16.5% Solution] Lots manufactured in 2019 and 2020