Silverback: FDA OKs NDA for epinephrine nasal spray for Allergic Reactions including Anaphylaxis

  Silverback Therapeutics, Inc. (Nasdaq: SBTX) (“Silverback”) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review ARS Pharmaceuticals, Inc.’s (ARS Pharma) New Drug Application (NDA) for neffy for the emergency treatment of allergic reactions (type I) including anaphylaxis in adults and children ≥30 kg (66 lbs). If approved by the FDA, neffy would be the first non-injectable treatment available to patients with allergic reactions (type I) including anaphylaxis.

The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date that is anticipated in mid-2023.

https://www.biospace.com/article/releases/silverback-therapeutics-inc-announces-the-fda-s-acceptance-of-ars-pharmaceuticals-nda-for-neffy-epinephrine-nasal-spray-for-the-treatment-of-allergic-reactions-type-i-including-anaphylaxis/