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FDA Approves Rafa Laboratories’ Midazolam Autoinjector

August 31, 2022

The FDA has approved Rafa Laboratories’ midazolam autoinjector for treatment of adult patients with status epilepticus, defined as seizures lasting five or more minutes.

The autoinjector, which delivers the treatment intramuscularly into the thigh, can also be administered through clothes. This means that it can be used more quickly during an emergency, when fast treatment reduces the likelihood of permanent damage from a continuous seizure.

The autoinjector can also be used to treat seizures resulting from nerve agent exposure.

The tool was developed by Israel-based Rafa with support from the U.S. Department of Defense’s Chemical and Biological Defense Program.

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