Silverback : FDA Accepts ARS Pharm's NDA For Neffy For Treatment Of Allergic Reactions

(RTTNews) - The U.S. Food and Drug Administration has accepted for review ARS Pharmaceuticals, Inc.'s New Drug Application (NDA) for neffy for the emergency treatment of allergic reactions (type I) including anaphylaxis in adults and children greater than or equal to 30 kg, Silverback Therapeutics Inc. (SBTX) said in a statement on Friday.

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

neffy has potential to be the first non-injectable medicine indicated to treat allergic reactions (type I) including anaphylaxis in the U.S., if approved.

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