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Xembify FDA Approval History

Last updated by Judith Stewart, BPharm on Aug 3, 2020.

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).

Development timeline for Xembify

Jul  4, 2019Approval FDA Approves Xembify (immune globulin subcutaneous) for Primary Immunodeficiencies

Further information

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