Complete Response Letters
ARS Pharmaceuticals, Inc.: Neffy
What FDA's Complete Response Letters to the company say, in the letters' own words.
Complete Response Letter, Sep 19, 2023
The submitted data do not provide substantial evidence of effectiveness for the use of ARS-1 (epinephrine nasal spray) for its proposed indication, the treatment of allergic reactions (Type 1), including anaphylaxis, in adult and pediatric patients who weigh 2 30 kg, under conditions likely to be encountered by the target population.
CRL_NDA214697_20230919:p1:s22If an NDSRI is detected above the recommended Al limit, the applicant should amend the application as appropriate.
CRL_NDA214697_20230919:p2:s23No. FDA-2023-P-2392) regarding Neffy (NDA 214697).
CRL_NDA214697_20230919:p4:s12The comments included in this communication reflect the deficiencies that CDER has determined preclude approval of the NDA in its current form, and do not represent a final decision by the Agency on approval of the NDA or the issues raised in the pending citizen petition.
CRL_NDA214697_20230919:p4:s14More Complete Response Letters
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