FDA accepts NDA for intranasal epinephrine from ARS Pharmaceuticals

neffy. [Image from ARS Pharmaceuticals]

ARS Pharmaceuticals announced today that the FDA accepted its new drug application (NDA) for neffy, its intranasal epinephrine.

The offering covers the emergency treatment of severe type I allergic reactions in children and adults weighing 30 kg (66 pounds) or more. The company set an anticipated target action date of mid-2023 for its PDUFA (Prescription Drug User Fee Act).

ARS Pharmaceutical developed neffy with the Neurelis Intravail transmucosal absorption enhancement technology. Intravail enhances drug absorption through the nasal mucosa. This enables the noninvasive delivery of protein, peptide and small-molecule drugs.

Get the full story at our sister site, Drug Delivery Business News.

Read more
  • 0