ADMA Biologics announced the FDA approved the Company’s supplemental Biologics License Application submitted under section 351(a) of the Public Health Service Act for BIVIGAM. The FDA approval represents the final study report for the Pediatric assessment as required in the post marketing commitment. Additionally, the approval provides for a revision of BIVIGAM’s prescribing information to expand the primary humoral immunodeficiency (“PI”) indication to pediatric patients 2 years of age and older.
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