FORT DETRICK, Md. – August 23, 2022 – The Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense’s (JPEO-CBRND’s) Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical (JPM CBRN Medical) received notice of U.S. Food and Drug Administration (FDA) approval of Rafa Laboratories, Ltd.’s (Rafa) midazolam injection autoinjector New Drug Application (NDA). The U.S. Department of Defense (DoD) developed the product with Rafa via JPM CBRN Medical’s Advanced Anticonvulsant System (AAS) program team. The DoD’s Chemical and Biological Defense Program supported this effort.
The midazolam injection autoinjector is indicated for the treatment of status epilepticus, or prolonged seizures, in adults. As such, this new AAS autoinjector can be used to treat seizures resulting from nerve agent exposure. The AAS improves upon and will replace the currently fielded convulsant antidote for nerve agent (CANA) diazepam autoinjector.