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# CRL for ARS Pharmaceuticals’ Neffy
- URL: https://www.fdaweb.com/crl-for-ars-pharmaceuticals-neffy/
- Published: 2023-09-20T12:00:00.000Z
- Updated: 2026-09-14T18:57:34.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155372

FDA has issued a complete response letter (CRL) to ARS Pharmaceuticals for its NDA for neffy (epinephrine nasal spray) to treat Type 1 allergic reactions, including anaphylaxis, in adults and some children. The company [says](https://ir.ars-pharma.com/news-releases/news-release-details/fda-issues-complete-response-letter-neffyr-epinephrine-nasal?ref=fdaweb.com) it will submit a formal dispute resolution request to appeal the CRL.

In the letter, FDA requested the completion of a pharmacokinetic/pharmacodynamic study assessing repeat doses of neffy compared to repeat doses of an epinephrine injection product under allergen-induced allergic rhinitis conditions to support approval, ARS says.

The company statement says the FDA Pulmonary-Allergy Drugs Advisory Committee voted 16-6 in 5/2023 to recommend that neffy should be approved for use in adults without the need for additional studies to demonstrate efficacy or safety. The vote to recommend approval for use in children was 17-5, the company says.

ARS says it had already agreed with FDA to do a repeat-dose study under allergen-induced allergic rhinitis conditions as a post-marketing study and says it is surprised that the agency now wants the study as part of the NDA.