(Reuters) -U.S. health regulators declined to approve a nasal spray that would have been the first needle-free emergency treatment for allergic reactions ...
- 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 -U.S.
The U.S. Food and Drug Administration , in its so-called"Complete Response Letter", asked the company to complete a repeat-dose study on the treatment before a potential approval, rather than after as was mutually agreed in August, ARS Pharma said late on Tuesday. Lowenthal was referring to a vote in May when a panel of advisers to the FDA voted 16 to 6 in favor of adults using Neffy and 17 to 5 in favor of children using the nasal spray.
The company's application was based on trials in healthy patients and in those having a rhinitis attack, with the nasal spray showing a comparable response to injectable products.
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