The FDA recorded a supplement dated 22 September 2026 to Gland Pharma's abbreviated new drug application for adrenaline (epinephrine). The record does not state what the supplement concerns; supplements to generic applications typically cover manufacturing, packaging or labelling alignment with the reference product.
This changes nothing about how adrenaline is used in anaphylaxis, cardiac arrest or shock. It is relevant mainly to supply: Gland is an Indian manufacturer, and generic injectable adrenaline availability affects emergency departments in India and abroad.
- This is a supplement to an existing generic, not a new approval or indication.
- Adrenaline dosing and indications are unchanged.
- Intramuscular adrenaline 0.5 mg (0.01 mg/kg in children) into the anterolateral thigh remains first-line for anaphylaxis.
- Check stock and expiry dates in resuscitation trolleys as routine.
Why it matters
Reliable generic supply of a core resuscitation drug matters more than the paperwork behind it.
Don't overread it
A licence supplement to a generic is not a new indication or safety signal.
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