Cuvitru FDA Approval History
Last updated by Judith Stewart, BPharm on March 2, 2021.
FDA Approved: Yes (First approved September 13, 2016)
Brand name: Cuvitru
Generic name: immune globulin subcutaneous (human)
Dosage form: Injection
Company: Shire plc
Treatment for: Primary Immunodeficiency Syndrome
Cuvitru (immune globulin subcutaneous (human)) is indicated as replacement therapy in the treatment of primary humoral immunodeficiency (PI).
Cuvitru is a ready-to-use injection administered via subcutaneous infusion at regular intervals from daily up to every two weeks.
Common side effects include infusion site reactions, headache, nausea, fatigue, diarrhea, and vomiting.
Development timeline for Cuvitru
| Date | Article |
|---|---|
| Sep 14, 2016 | Approval Shire Announces FDA Approval of Cuvitru [immune globulin subcutaneous (human)] for Primary Immunodeficiency |
Further information
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