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.
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