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FDA NEWS RELEASE
FOR IMMEDIATE RELEASE
FDA Approves Treatment for Nerve-Poisoning Agents for Use by Trained Emergency Medical Services Personnel
The U.S. Food and Drug Administration (FDA) today approved Duodote (atropine and pralidoxime chloride injection) for use by trained emergency medical services personnel to treat civilians exposed to life-threatening organophosphorus-containing nerve agents, such as sarin, and insecticides. Duodote is manufactured by Meridian Medical Technologies, Inc., Columbia, Md.
FDA previously approved atropine and pralidoxime chloride injection under the name Antidote Treatment--Nerve Agent Auto-Injector (ATNAA) for military use. Developed by the U.S. Army and manufactured by Meridian Medical Technologies, Inc., ATNAA is not available for use in civilians. ATNAA was approved on Jan. 17, 2002, for use by the military to treat troops who have been exposed to toxic nerve agents that cause loss of muscle control and death from respiratory failure. The two constituent drugs in ATNAA were previously approved for use separately. Atropine autoinjector has been approved for use in adults since 1973, and its use in children and adolescents was approved in June 2003. Pralidoxime was first approved for use in 1964.
"Today's approval facilitates the stockpiling of the product so that it can be used to treat civilians in an emergency," said Douglas Throckmorton, M.D., deputy director of FDA's Center for Drug Evaluation and Research. "The approval contains two caveats: the primary protection against exposure to chemical nerve agents and insecticide poisoning is the wearing of protective clothing; and Duodote may be administered only by well-trained emergency medical personnel."
The manufacturer will distribute Duodote directly to emergency medical service organizations or their suppliers.