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August 16, 2024

OctaplasLG Powder Authorized for Emergency Use by FDA

By America's Blood Centers

The U.S. Food and Drug Administration (FDA) recently announced that it has granted an emergency use authorization (EUA) on August 8th to Octapharma Pharmazeutika Produktionsgesellschaft mbH for use of octaplasLG Powder (blood group types A and AB). The agency announcement explained that the EUA is for, “U.S. military forces for the treatment of hemorrhage or coagulopathy during an emergency involving agents of military combat (e.g., firearms, projectiles, and explosive devices) when plasma is not available for use or when the use of plasma is not practical.” According to the agency, “octaplasLG powder is a powdered freeze-dried product that can be used following reconstitution (adding water back to the powder) in settings where refrigeration is not available, thus enabling the rapid availability of plasma for use at the point of injury.”

FDA noted that, “[h]emorrhage, sometimes accompanied by coagulopathy (a condition that affects the blood’s ability to clot), is a leading cause of death among combat trauma casualties. Plasma contains proteins that may be effective at helping clot blood and can be used for the management of hemorrhage and coagulopathy. However, its use in combat settings is severely limited by logistical and operational challenges such as the need for refrigeration and, in the case of frozen plasma, a long thawing period.”

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