Xembify FDA Approval History
Last updated by Judith Stewart, BPharm on July 30, 2024.
FDA Approved: Yes (First approved July 3, 2019)
Brand name: Xembify
Generic name: immune globulin subcutaneous, human - klhw
Dosage form: Injection
Company: Grifols
Treatment for: Primary Immunodeficiency Syndrome
Xembify (immune globulin subcutaneous, human- klhw) is a 20% immune globulin solution for subcutaneous injection indicated for treatment of Primary Humoral Immunodeficiency (PI) in patients 2 years of age and older.
Development timeline for Xembify
| Date | Article |
|---|---|
| Jul 29, 2024 | Approval Grifols Receives Approval for Expanded Xembify (immune globulin subcutaneous human-klhw) Label in U.S. |
| Jul 4, 2019 | Approval FDA Approves Xembify (immune globulin subcutaneous) for Primary Immunodeficiencies |
Further information
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