Rafa receives FDA approval for autoinjector to deal with standing epilepticus in adults

August 31, 2022

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Rafa Laboratories introduced the FDA has granted approval for its 10 mg midazolam autoinjector to deal with standing epilepticus in adults.

In response to a launch issued by Rafa, the midazolam injector was created in collaboration with the U.S. Division of Protection’s Joint Program Government Workplace for Chemical, Organic, Radiological and Nuclear Protection (JPEO-CBRND). The 2 entities beforehand partnered to develop Rafa’s atropine autoinjector, which launched within the U.S. in 2017.

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The midazolam autoinjector can be utilized to deal with seizures ensuing from nerve agent publicity, and, in accordance with the U.S. JPEO-CBRND, it improves upon and can change the at present fielded convulsant antidote for nerve agent diazepam autoinjector.

“We’re happy with the FDA approval for this life-saving product,” Rafa CEO Amir Levin acknowledged within the launch. “It’s made in Israel and is significant information to the world of medical emergency options, thus strengthening Rafa’s key function in offering dependable merchandise to armies, governments and first responders worldwide.”

Rafa mentioned within the launch that intramuscular midazolam is a first-line remedy for status epilepticus in accordance with pointers of the American Epilepsy Society. Rafa’s autoinjector, which could be administered instantly within the thigh or by garments, doesn’t require an IV line and might be advantageous in a area setting throughout an emergency, when quick remedy reduces the chance of everlasting injury that might end result from a steady seizure, in accordance with the discharge.

“Medical research confirmed the correlation between early remedy of standing epilepticus and a diminished danger of an ongoing and irreversible neurological injury,” Roy Shay, head of emergency options at Rafa, mentioned within the launch. “This product might help in saving many lives across the globe.”

FDA approval of the brand new autoinjector was obtained following an expedited evaluation with new drug utility submission, with ultimate approval achieved in lower than 5 months by prioritized engagement between the protection division and the FDA, the corporate acknowledged.


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