FDA BRIEF: Week of June 12, 2017

FDA approved


SYMJEPI (epinephrine injection)

Adamis Pharmaceuticals Corporation

INDICATION:

Emergency treatment of allergic reactions (Type I) including anaphylaxis  to stinging insects (e.g., order Hymenoptera, which include bees, wasps, hornets, yellow jackets and fire ants) and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis.

For immediate administration in patients who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions.

Anaphylactic reactions may occur within minutes after exposure and consist of flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with a fall in blood pressure, convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, wheezing, dyspnea due to laryngeal spasm, pruritus, rashes, urticaria or angioedema.

For immediate administration as emergency supportive therapy only and is not a
substitute for immediate medical care.

ADDRESSING UNMET NEED: New drug alternative to EpiPen

REG PATHWAY: NDA

  • 505(b)(2) pathway
  • Postmarketing Commitment: Fault Tree Analysis and quantification to support device reliability specification

MECHANISM OF ACTION: Acts on both alpha and beta-adrenergic receptors

EFFICACY & SAFETY: Established based on initial approval in 1939

LABEL


Image credit: Adamis

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