Efficacy of epinephrine pre-filled syringe in patients with type I allergic reactions including anaphylaxis

Trial Profile

Efficacy of epinephrine pre-filled syringe in patients with type I allergic reactions including anaphylaxis

Completed
Phase of Trial: Phase III

Latest Information Update: 15 Jun 2017

At a glance

  • Drugs Epinephrine (Primary)
  • Indications Anaphylaxis; Immediate hypersensitivity
  • Focus Registrational; Therapeutic Use
  • Most Recent Events

    • 15 Jun 2017 According to a company media release, the US FDA has approved Adamis' epinephrine injection, USP, 1:1000 (0.3 mg Pre-filled single dose syringe) (PFS) for the emergency treatment of allergic reactions (Type I) including anaphylaxis. The FDA has also approved the PFS trade name of Symjepi.
    • 12 Apr 2016 According to an Adamis Pharmaceuticals media release, FDA agency action date (PDUFA date) for Epinephrine Pre-filled Syringe (PFS) is 4 Jun 2016.
    • 07 Dec 2015 According to a media release, Adamis Pharmaceuticals has resubmitted the NDA to the U.S. FDA for its epinephrine pre-filled syringe (PFS) for the emergency treatment of anaphylaxis.
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