The U.S. Food and Drug Administration declined to approve a nasal spray to treat severe allergic reactions, calling for more research on what would have been the first alternative to injections using devices such as an EpiPen.
Federal regulators declined to approve a nasal spray to treat severe allergic reactions late Tuesday, calling for more research on what would have been the first alternative to injections using devices such as an EpiPen.
The move comes four months after an FDA advisory committee recommended approval of the device, dubbed neffy. The FDA is not required to follow the committee’s recommendations, though it usually does. The ARS product is one of several needle-free devices being developed to treat dangerous reactions to food, insect stings and medications. Such a device could alter treatment for the between 33 million and 45 million Americans with severe allergies to food and other triggers.
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