It is made in Israel and is meaningful news to the world of medical emergency solutions, thus strengthening Rafa's key role in providing reliable products to armies, governments, and first responders worldwide." It is already sold under EUA in other territories and is an important addition to Rafa's current autoinjector portfolio, which includes various formulations for emergency use.Īmir Levin, CEO of Rafa, stated: "We are proud of the FDA approval for this life saving product. The product was developed in Israel and is manufactured at Rafa's manufacturing site in Jerusalem. This is a significant advantage in a field setting during an emergency, when fast treatment reduces the likelihood of permanent damage that could result from a continuous seizure. Rafa's innovation resides in the use of an autoinjector to be administered intra muscularly to the thigh (can be administered through clothes as well), in a simple and fast manner which does not require an intravenous line. According to guidelines of the American Epilepsy Society, Midazolam Intra-muscular is a first-line therapy for Status Epilepticus. JPEO-CBRND, the autoinjector improves upon and will replace the currently fielded convulsant antidote for nerve agent (CANA) diazepam autoinjector.įDA approval was obtained following an expedited review, a testament to the importance and urgent need of the product, with NDA submission and final approval achieved in less than five months through prioritized engagement between the U.S. As such, this new autoinjector can be used to treat seizures resulting from nerve agent exposure. ![]() The Midazolam 10 mg autoinjector is indicated for the treatment of status epilepticus, or prolonged seizures, in adults.
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