Yet another life-saving drug that the FDA refused to approve (against the advice of the advisory committee). This refusal to approve certainly has resulted in deaths. But hey, we have to protect Big Pharma profits, that's a lot more important than kids dying.
What makes it even worse is that the drug is epinephrine, the active ingredient in the EpiPen, and they refused to approve an easier delivery system.
Remember how they jacked the price up of the EpiPens by something like 300% when the FDA refused to approve a generic?

Quote:

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Earlier this year, the FDA had the opportunity to approve Neffy, a needle-free, low-dose intranasal epinephrine nasal spray developed by ARS Pharmaceuticals. Even though the agency had strong evidence of the product’s safety and efficacy, in a surprise move, regulators declined to clear the therapeutic for use. Instead, they requested completion of a pharmacokinetic/pharmacodynamic efficacy study assessing repeat doses of the drug, compared with repeat doses of an epinephrine injection project under allergen-induced allergic rhinitis conditions to support approval. I am aware of no independent expert who endorsed FDA’s request for additional information.
https://www.statnews.com/2023/12/29/neffy-sub...e=hs_email

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