The FDA approvals database records a supplement dated 19 October to new drug application 204200 for Adrenalin (epinephrine), held by PH Health. The record available to us does not describe what the supplement changes.
Supplements to an approved application commonly cover labelling, manufacturing, packaging or formulation. Without the label text, there is no basis to say that dosing, indications or safety advice have changed. Check the FDA label before acting.
This notice concerns one US-approved product. Epinephrine products in India are approved separately and are not affected by it.
- An FDA supplement to an epinephrine application was recorded on 19 October.
- Its content is not stated in the record; check the label before assuming a change.
- A supplement is not a new indication.
- Resuscitation and anaphylaxis dosing remain as per current guidelines.
Why it matters
Epinephrine is a core emergency drug, so label changes are worth tracking when their content is clear.
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