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First nalaxone nasal spray approved by the FDA

The  U.S. Food and Drug Administration  approved the first generic version of naloxone nasal spray that can be used to reverse suspected overdose in the community setting, by individuals without medical training.

It is made by Israel’s Teva Pharmaceuticals Industries Ltd. This is the first generic naloxone hydrochloride nasal spray that the FDA has approved. It’s a life saving emergency medication to reverse overdose. It will be available for over-the-counter purchasing. On average, opioids kill more than 130 Americans every day. Almost 400,000 people died from an opioid overdose between 1999 and 2017, according to the Centers for Disease Control and Prevention.

TEVA

Douglas Throckmorton, deputy center director for regulatory programs in the FDA’s Center for Drug Evaluation and Research, said in a statement that the spray will make “emergency overdose reversal treatment” more accessible and available. Having access to naloxone is an important step. “All together, these efforts have the potential to put a vital tool for combatting opioid overdose in the hands of those who need it most – friends and families of opioid users, as well as first responders and community-based organizations,” he added.

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