The FDA's drug approvals database lists a supplement dated 22 September 2026 to an abbreviated new drug application (ANDA 219239) for epinephrine, held by Gland. Epinephrine is used in resuscitation, anaphylaxis and as a vasopressor.
The entry does not say what the supplement changed, and nothing in it points to a safety communication or a new indication. A supplement to a generic application can cover manufacturing, labelling or other administrative changes. For prescribers, the practical step is to read the current product information if you use this product. This is an FDA record only; it says nothing about the product's status in India.
- The FDA entry is a supplement to a generic application; its content is not described.
- Check the current product information if you stock this epinephrine product.
- No change in how epinephrine is used is indicated by this entry alone.
Why it matters
Regulatory entries range from safety alerts to paperwork, and this one gives no reason to change practice.
Don't overread it
A supplement to a generic application is not a new indication or a safety warning.
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