FDA Approves First Nasal Spray for Treatment of Anaphylaxis
Today, the U.S. Food and Drug Administration approved neffy (epinephrine nasal spray) for the emergency treatment of allergic reactions (Type I), including those that are life-threatening...
This document provides guidance for industry on the chemistry, manufacturing, and controls (CMC) documentation that should be submitted in new drug applications (NDAs) and abbreviated new drug...
FDA approves nasal spray as first needle-free treatment for …
The FDA has approved a nasal spray as the first needle-free treatment for potentially fatal allergic reactions. The spray is intended as an alternative to EpiPen and other autoinjectors.
Epinephrine Nasal Spray to Treat Anaphylaxis is Now Available
Aug 9, 2024 · Epinephrine auto-injectors received FDA approval in 1987 and have been the standard treatment for anaphylaxis ever since. The new nasal spray is a needle-free alternative to the auto-injector devices. It is a 2 mg spray approved for adult and pediatric patients weighing at least 66 pounds.
5 Things to Know About neffy, the New Nasal Spray for Anaphylaxis
Oct 8, 2024 · The Food and Drug Administration (FDA) approved neffy in August 2024 for adults and children who weigh at least 66 pounds after giving the product a “Fast Track” designation, which expedites the review of drugs that fill an unmet need for people with serious conditions. Anaphylaxis can affect the whole body, cause such complications as ...
FDA approves first nasal spray to treat anaphylaxis
Aug 9, 2024 · The Food and Drug Administration (FDA) has approved neffy epinephrine nasal spray from ARS Pharmaceuticals for the emergency treatment of anaphylaxis in people weighing at least 66 pounds. It is the first treatment that does not require an injection.
FDA Approves First Over-the-Counter Naloxone Nasal Spray
Today, the U.S. Food and Drug Administration approved Narcan, 4 milligram (mg) naloxone hydrochloride nasal spray for over-the-counter (OTC), nonprescription, use – the first naloxone...
FDA Approves First Nasal Spray for Allergic Reactions - WebMD
Aug 9, 2024 · The FDA announced its approval of the nasal spray, called neffy, on Friday. It's for adults, and for children who weigh at least 66 pounds, who have what are known as type 1 allergic reactions,...
FDA Approves First Nasal Spray for Treatment of Anaphylaxis
SILVER SPRING, Md., Aug. 9, 2024 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved neffy (epinephrine nasal spray) for the emergency treatment of allergic reactions (Type...
Nasal spray Neffy gets FDA approval to treat allergic reactions - USA TODAY
Aug 9, 2024 · The Food and Drug Administration approved a new nasal spray Friday as the first needle-free emergency treatment for potentially fatal allergic reactions.