A committee of the Food and Drug Administration's outside advisers voted Thursday in favor of an epinephrine nasal spray product, clearing a key hurdle for what could soon be the first needle-free option for treating severe allergic reactions.
While the FDA is not legally bound to follow advisory committee votes, the agency
, but are uncomfortable using injection options currently on the market — like the EpiPen, first approved by the FDA in 1987. "If they don't have it with them, it's a moot point. They don't deliver, they don't have drug, they go to the hospital," Richard Lowenthal of ARS Pharmaceuticals told the committee.
Instead of running massive clinical trials, drugmakers can often earn approval by showing their product triggers similar measurements in the body compared to already-approved medications.
United States Latest News, United States Headlines
Similar News:You can also read news stories similar to this one that we have collected from other news sources.
FDA panel backs first over-the-counter birth control pill in USThe committee's recommendation means the agency is likely to formally approve the drug this summer.
Read more »
FDA Approves First Drug to Treat Alzheimer's AgitationThe antipsychotic brexpiprazole (Rexulti) is the first FDA-approved treatment option for agitation associated with Alzheimer's disease.
Read more »
2023 Land Rover Defender 130 First Edition P400 First Drive: Going Big!It’s designed to keep on going when the road runs out. But Land Rover’s biggest Defender is also a brilliant long-distance highway cruiser.
Read more »
Joel Embiid makes first All-NBA first team alongside Giannis Antetokounmpo; Nikola Jokić makes second teamNBA MVP Joel Embiid headlines the All-NBA first team that was announced Monday.
Read more »
José Abreu, struggling at plate for Astros, gets a day offIn his first season with Astros, the first baseman is hitting .218 with no homers,
Read more »
‘Caught between a rock and a hard place’: FDA considers over-the-counter birth controlThe agency is slated to make a decision on approval of the daily hormonal pill by this summer.
Read more »