ADMA Biologics, Inc. announced the FDA approval for its supplemental Biologics License Applications (BLAs) for both ASCENIV and BIVIGAM to now include room temperature (25°C) storage conditions for up to 4 weeks during the first 24 months of the 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.
“With today’s announced approval, the Company anticipates reaching more customers otherwise inaccessible due to limited refrigeration space and cold chain capacity constraints; this approval meaningfully alleviates these supply chain restrictions,” said Adam Grossman, President and Chief Executive Officer of ADMA. “The approval of room temperature storage for ASCENIV and BIVIGAM is a meaningful enhancement of each product’s go-to market offering as it should provide for more versatile utilization and inventory management by providers.”
The newly approved room temperature storage labeling for ASCENIV and BIVIGAM is immediately effective, and product is commercially available to U.S. healthcare providers and patients.
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