Despite AdComm Endorsement, neffy Nasal Spray Alternate for EpiPen Gets CRL

ARS Pharmaceuticals announced that the FDA issued a complete response letter (CRL) on its NDA for neffy (epinephrine nasal spray) after having received a recommendation for approval from the agency’s Pulmonary-Allergy Drugs Advisory Committee in May.

According to ARS Pharma, the FDA now requires that a “repeat-dose study be completed prior to neffy approval as opposed to previously agreed-upon post-marketing requirement.” The repeat dose study will assess doses of neffy compared to doses of an epinephrine injection product under allergen-induced allergic rhinitis conditions.

The FDA and ARS Pharma previously had agreed in August, ARS said, on “final physician’s labeling and a post-marketing requirement to conduct this study as informative for labeling.”

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