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# More Data Needed for Neffy ANDA: Viatris
- URL: https://www.fdaweb.com/more-data-needed-for-neffy-anda-viatris/
- Published: 2023-06-13T12:00:00.000Z
- Updated: 2026-09-14T18:38:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154683

Viatris is petitioning FDA to require additional pharmacokinetic (PK) and pharmacodynamic (PD) studies to support an NDA submitted by ARS Pharmaceuticals for neffy (epinephrine nasal spray) or ARS-1 intranasal epinephrine for the emergency treatment of Type 1 allergic reactions, including anaphylaxis, in adults and some children. The [petition](https://downloads.regulations.gov/FDA-2023-P-2392-0001/attachment%5F1.pdf?ref=fdaweb.com) says the evidence presented at a 5/11 Pulmonary-Allergy Drugs Advisory Committee meeting that considered the NDA did not sufficiently address issues previously raised by Viatris.

“Viatris believes the totality of currently available evidence does not yet answer several critical questions regarding how ARS-1 will perform in a real-world anaphylaxis event,” the letter says. “Additional PK/PD studies that are carefully tailored to reflect real-world conditions of use for ARS-1 could materially reduce residual uncertainties regarding the safety and effectiveness of ARS-1.”

Viatris acknowledges in the letter that its Mylan Specialty unit is the application holder for Epipen (epinephrine injection) and Epipen Jr. (epinephrine injection) auto-injectors. “We support providing improved access to reliable, safe, and effective treatments for use in an emergency anaphylaxis event,” the company says, “but also recognize the seriousness of unresolved uncertainties regarding the efficacy and safety of a new (and fundamentally different) route of administration and dosage form for treating anaphylaxis with epinephrine.”