(Reuters) - The U.S. Food and Drug Administration (FDA) has declined to approve ARS Pharmaceuticals' nasal spray for allergic reactions and requested ...
- The U.S. Food and Drug Administration has declined to approve ARS Pharmaceuticals' nasal spray for allergic reactions and requested completion of a repeat-dose study to support aMusicians, humour and stories galore help Bruce Guthro's Celebration of Life | SaltWire - The U.S.
"We are very surprised by this action and the late requirement at this time to change the repeat-dose study from a post-marketing requirement, which we had previously aligned on with FDA, to a pre-approval requirement, particularly given the positive Advisory Committee vote," CEO Richard Lowenthal said.
Anaphylaxis is a life-threatening allergic reaction that can occur within seconds of being exposed to an allergen. The company's application was based on trials in healthy patients and in those having a rhinitis attack. The nasal spray showed a comparable response to injectable products in delivering epinephrine.
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