ADMA - ADMA Biologics gets FDA approval to extend shelf life of Asceniv Bivigam
ADMA Biologics (NASDAQ:ADMA) said the U.S. Food and Drug Administration (FDA) approved to extend the expiration dating to 36 months from 24 months for its Asceniv and Bivigam immune globulin (IG) drug product stored at 2-8°C. The company said the expiration date extension applies to all existing Asceniv and Bivigam lots currently in the commercial supply chain as well as to future production of ASCENIV and BIVIGAM in all vial sizes. Bivigam (immune globulin intravenous, human) is used to treat primary humoral immunodeficiency. Asceniv is used to treat the symptoms of primary immunodeficiency syndrome, among other things. ADMA +4.67% premarket to $1.57
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ADMA Biologics gets FDA approval to extend shelf life of Asceniv, Bivigam