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Regulatory · 03 of 05

FDA records a supplement to an approved epinephrine (Adrenalin) application

No change to how adrenaline is used in anaphylaxis or cardiac arrest follows from this record.

The FDA drugs database lists a supplement dated 19 October 2026 to an approved epinephrine application marketed as Adrenalin. The record gives the applicant and product but not the content of the change.

Nothing in the record suggests a safety finding. The product is a US listing, and nothing in the record bears on adrenaline preparations used in India.

  • The supplement relates to NDA 204200 for epinephrine, held by PH Health.
  • It was recorded on 19 October 2026.
  • Supplements often cover labelling, packaging or manufacturing.
  • Label adrenaline by mg/mL rather than ratio to reduce dosing errors.

Why it matters

Adrenaline formulations and labels change often, and confusion between concentrations is a known source of error.

Don't overread it

A licence supplement is not a new indication, and the record does not say what changed.

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