The FDA's drug approvals database recorded a supplement on 22 September to abbreviated new drug application 219239, for generic epinephrine from Gland.
An ANDA supplement is a change to an existing generic approval, typically covering manufacturing, labelling or packaging. The database entry does not say what changed. It is not a new indication, a new formulation for patients, or a safety communication.
For emergency clinicians, nothing about how epinephrine is used changes. Its relevance is supply: epinephrine for injection is an essential emergency drug, and generic manufacturers support availability.
- Make no change to epinephrine dosing or use on the basis of this notice.
- Check that resuscitation and anaphylaxis kits are stocked with in-date epinephrine.
- Report any local supply problem through your pharmacy so alternatives can be sourced.
Why it matters
Only as a reminder that supply of an essential emergency drug depends on generic manufacturers.
Don't overread it
A licence supplement is not a new indication or a safety finding.
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