Adma Biologics, Inc. Announces FDA Approvals of Extended Room Temperature Storage Conditions for Asceniv & Bivigam
March 11, 2024 at 11:00 am
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ADMA Biologics, Inc. announced the United States Food and Drug Administration?s (?FDA?) approval for its supplemental Biologics License Applications (BLAs) for both ASCENIV and BIVIGAM to extend the approved 4-week room temperature (25°C) 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.
ADMA Biologics, Inc. is an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty biologics for the treatment of immunodeficient patients at risk for infection and others at risk for certain infectious diseases. The Company manufactures and markets three United States Food and Drug Administration (FDA)-approved plasma-derived biologics for the treatment of immune deficiencies and the prevention of certain infectious diseases: BIVIGAM (immune globulin intravenous, human) for the treatment of primary humoral immunodeficiency (PI); ASCENIV (immune globulin intravenous, human - slra 10% liquid) for the treatment of PI, and NABI-HB (hepatitis B immune globulin, human) to provide enhanced immunity against the hepatitis B virus. Through its ADMA BioCenters subsidiary, the Company also operates as an FDA-approved source plasma collector in the United States, which provides its blood plasma for the manufacture of its products.