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ADMA Biologics Announces FDA Approval for Room Temperature Storage of ASCENIV™ & BIVIGAM®
FDA approvals for both ASCENIV and BIVIGAM provide for room temperature (25°C) storage conditions for up to 4 weeks during the first 24 months of the 36-month
About this update from Adma Biologics Inc
[{"type":"text","content":"FDA approvals for both ASCENIV and BIVIGAM provide for room temperature (25°C) storage conditions for up to 4 weeks during the first 24 months of the 36-month approved shelf life Provides for improved inventory management and ease of product administration to patients Approval for ambient storage conditions for ASCENIV & BIVIGAM is immediately effective and now commercially available to U.S. healthcare providers RAMSEY, N.J. and BOCA RATON, Fla., Dec. 13, 2022 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ: ADMA) (“ADMA” or the “Company”), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics, today announced the United States Food and Drug Administration’s (“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. About ADMA Biologics, Inc. (ADMA) ADMA Biologics is an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics for the treatment of immunodeficient patients at risk for infection and others at risk for certain infectious diseases. ADMA currently manufactures and markets three United States Food and Drug Administration (FDA) approved plasma-derived biologics for the treatment of immune de...