ADMA Biologics announces FDA approval of sBLAs for ASCENIV, BIVIGAM

ADMA Biologics announced the United States Food and Drug Administration’s approval for its supplemental Biologics License Applications for both ASCENIV and BIVIGAM to extend the approved 4-week room temperature storage conditions during the first 24 months of shelf life, to allow for a 4-week room temperature storage at any time during the entire 36-month approved shelf life. The room temperature approval applies to all existing ASCENIV and BIVIGAM lots currently in the commercial supply chain as well as to future production of ASCENIV and BIVIGAM. The newly approved extension of room temperature storage conditions for both ASCENIV and BIVIGAM is immediately effective, and both products are commercially available to U.S. healthcare providers and patients.