On 14 October 2026 the FDA recorded a supplement to abbreviated new drug application 078452, held by Aurobindo Pharma for generic risperidone.
Supplements to generic applications usually cover manufacturing, labelling alignment with the reference product, or packaging. The FDA listing does not state the content of this one, and nothing in it indicates a new safety concern or a change in indication.
Aurobindo supplies generic medicines widely, including in India. Prescribers need make no change on the strength of this record.
- No change to risperidone prescribing is needed from this record.
- Generic supplements usually concern manufacturing or labelling alignment.
- Check the FDA label if a specific formulation question arises.
- Report any unexpected adverse effect with a generic switch through the usual pharmacovigilance route.
Why it matters
Most regulatory activity on established psychotropics is administrative, and knowing that prevents unnecessary switches.
Don't overread it
A licence supplement is not a new indication or a safety finding.
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