Epinephrine pre-filled syringe - Adamis Pharmaceuticals Corporation

Drug Profile

Epinephrine pre-filled syringe - Adamis Pharmaceuticals Corporation

Alternative Names: Epinephrine injection PFS - Adamis Pharmaceuticals; Epinephrine PFS - Adamis Pharmaceuticals; Symjepi

Latest Information Update: 14 Feb 2018

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At a glance

  • Originator Adamis Pharmaceuticals Corporation
  • Class Antiarrhythmics; Antihaemorrhagics; Antihypotensives; Bronchodilators; Catecholamines; Ethanolamines; Small molecules
  • Mechanism of Action Adrenergic receptor agonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity No

Highest Development Phases

  • Registered Anaphylaxis

Most Recent Events

  • 15 Mar 2018 Adamis Pharmaceuticals Corporation expects FDA approval for epinephrine pre-filled syringe (0.15mg) in 2018
  • 12 Feb 2018 The US FDA is targeting 03/09/2018 to communicate proposed labelling and, if required, any postmarketing requirement/commitment requests for epinephrine pre-filled syringe's (0.15mg) sNDA for Anaphylaxis (In adolescents, In children [weighing 33 - 65 pounds])
  • 09 Feb 2018 The US FDA accepts sNDA for epinephrine pre-filled syringe (0.15mg) for Anaphylaxis (In adolescents, In children [weighing 33 - 65 pounds]) for review
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