The FDA recorded a supplement on 16 September to abbreviated new drug application 202862, Macleods Pharmaceuticals' generic olanzapine. The record does not state what the supplement covers. Supplements to generic applications are most often manufacturing, labelling or packaging changes.
Nothing in the record indicates a safety signal or a change in how olanzapine should be prescribed. Macleods is an Indian manufacturer, so the change may reflect supply to both markets, but its content and any CDSCO action are unknown.
- No change to prescribing or monitoring follows from this record.
- Continue metabolic monitoring for olanzapine as usual.
- If patients report a change in tablet appearance, reassure and confirm the product.
Why it matters
It tells you the regulatory sweep has been checked and there is nothing new for olanzapine prescribers.
Don't overread it
A licence supplement is not a new indication or a safety warning.
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