ADMA - Adma gets FDA approval for room temperature storage of Asceniv Bivigam

• Adma Biologics ( NASDAQ: ADMA ) said the U.S. Food and Drug Administration (FDA) approved the room temperature (25°C) storage conditions of for its Asceniv and Bivigam immune globulin ( IG ) drug products for up to 4 weeks during the first 24 months of the 36-month approved shelf life.
• "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 Adma President and CEO Adam Grossman.
• The FDA had approved supplemental Biologics License Applications (sBLAs) for the products.
• The company added that the newly approved labeling for Asceniv and Bivigam is immediately effective, and product is commercially available to U.S. healthcare providers and patients.
• In March, the FDA approved to extend the shelf life of Asceniv and Bivigam to 36 months from 24 months.

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