An official website of the United States government Here’s how you know

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

In this section: Approved Blood Products

CUVITRU

STN: BL 125596
Proper Name: Immune Globulin Subcutaneous (Human), 20% Solution
Tradename: CUVITRU
Manufacturer: Baxalta US, Inc.
Indication:

Replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients two years of age and older.

Product Information

Package Insert - CUVITRU

Supporting Documents

September 23, 2021 Approval Letter - CUVITRU
Clinical Review - CUVITRU
Statistical Review - CUVITRU
Supporting Documents older than three years - CUVITRU
Approval History, Letters, Reviews, and Related Documents - CUVITRU

Top