RAMSEY, N.J. and BOCA RATON, Fla. - ADMA Biologics, Inc. (NASDAQ: NASDAQ:ADMA), a biopharmaceutical company, announced today the FDA's approval of its supplemental Biologics License Applications for ASCENIV and BIVIGAM. This approval allows these products to be stored at room temperature (25°C) for up to four weeks at any point during their 36-month shelf life. Previously, this was only permissible during the first 24 months.
The FDA's decision is applicable to all existing lots of ASCENIV and BIVIGAM in the commercial supply chain, as well as future production. The company anticipates that the extended storage conditions will enable better inventory management and ease of administration for healthcare providers, potentially expanding the reach of these products to customers with limited refrigeration capabilities.
ASCENIV and BIVIGAM are intravenous immune globulin products used in the treatment of primary humoral immunodeficiency (PI). The approval for extended ambient storage conditions is effective immediately, with both products available to U.S. healthcare providers.
ADMA Biologics operates an FDA-licensed plasma fractionation facility in Boca Raton, Florida, and through its ADMA BioCenters subsidiary, it also collects source plasma. The company's mission includes the development and marketing of specialty biologics for immune-compromised patients.
This recent regulatory update is based on a press release statement from ADMA Biologics and has not been independently verified. The company holds several U.S. and foreign patents related to its products and product candidates. Further information can be found on the company's website.
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