FDA adcomm votes in favor of ARS Pharmaceuticals' EpiPen alternative
An advisory committee of outside experts to the FDA today voted 16-6 in favor of ARS Pharmaceuticals’ EpiPen alternative for adults (and 16-5 for children who weigh about 66 pounds or more) which, if approved, would be the first epinephrine nasal spray on the US market.
The vote was a surprise as multiple adcomm members questioned the nasal spray’s benefit-risk profile, and called for some clinical data on the nasal spray to be produced before it can be approved, although some questioned whether a smaller clinical study might be enough.
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