Posted by Michael Wonder on 11 Sep 2024
ARS Pharmaceuticals submits sNDA to FDA for neffy 1 mg dose for paediatric patients with type I allergic reactions who weigh 15 to 30 kg (33-66 lbs)
9 September 2024 - ARS Pharmaceuticals announced today the submission of a supplemental new drug application for neffy 1 mg for the treatment of type I allergic reactions, including anaphylaxis, in children who weigh 15 to 30 kg (33-66 lbs).
Pharmacokinetic data for neffy 1mg were slightly higher than that of adults who receive the same dose and pharmacodynamic response was similar.
