FDA considering first epinephrine nasal spray, alternative to EpiPen
If approved, the spray would be available for adults and children weighing more than 66 pounds.
Published: Sep. 19, 2023 at 5:46 PM CDT
NASHVILLE, Tenn. (WSMV) - The U.S. Food and Drug Administration (FDA) will decide whether to approve an epinephrine nasal spray used to treat severe allergic reactions and anaphylaxis.
If approved, the spray would be available for adults and children weighing more than 66 pounds.
ARS Pharmaceuticals makes the product, which is called neffy. The company said the FDA had a PDUFA target action date of Sept. 19.
An FDA advisory committee had previously given neffy a positive benefit-risk assessment at a meeting in May.
Neffy has gathered support for not requiring a needle, unlike the traditional EpiPen.
WSMV4 has reached out to ARS Pharmaceuticals and the FDA for an update about today’s scheduled decision.
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