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Adamis’ Anaphylaxis Treatment Rejected by the FDA

Amanda Tejuca4 months ago

The U.S. Food and Drug Administration (FDA) has denied approval for an Adamis anaphylaxis drug for a second time.

About the FDA Decision

Accordign to Reuters, the FDA rejected Adamis Pharmaceutical Corp’s emergency treatment for acute anaphylaxis for the second time last week.

The epinephrine injection, a pre-filled single-dose treatment, was recently reviewed again by FDA regulators. In March 2015, the FDA rejected the medication for the first time on concerns about the volume of dose delivered by the syringe.

The second proposal was rejected on claims that it should undergo additional testing. Adamis will go through with the required testing and expects to submit yet another proposal by the second half of 2016.

Symptoms of Anaphylaxis

Anaphylaxis is a severe allergic reaction. Reuters Health defines it as a serious, sometimes fatal, allergic reaction, which can occur rapidly due to exposure to an allergen including food, insect stings, medications or latex.

Symptoms include:

  • fainting, lightheadedness, low blood pressure, dizziness, or flushing
  • difficulty breathing, rapid breathing, shortness of breath, or wheezing
  • hives, swelling under the skin, blue skin from poor circulation, or rashes
  • nausea or vomiting
  • fast heart rate, feeling of impending doom, itching, tongue swelling, difficulty swallowing, facial swelling, mental confusion, nasal congestion, or impaired voice

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