ADMA Biologics: BIVIGAM Gets FDA Approval For Treating PI In Patients Aged 2 Years And Older

(RTTNews) - ADMA Biologics, Inc. (ADMA) announced the FDA has approved the company's supplemental Biologics License Application for BIVIGAM. The approval provides for a revision of BIVIGAM's prescribing information to expand the primary humoral immunodeficiency indication to pediatric patients 2 years of age and older. Previously, the indication for BIVIGAM was restricted to PI patients aged 12 years and older.

BIVIGAM was approved by the FDA in May 2019 and is indicated for the treatment of primary humoral immunodeficiency, including, the group of genetic disorders: X-linked and congenital agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome, and severe combined immunodeficiency.

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