On 14 October FDA recorded a supplement to an abbreviated new drug application for generic olanzapine held by Cadila Pharmaceuticals. The listing gives no detail of what the supplement changes. Supplements to generic applications usually cover manufacturing, labelling alignment or packaging rather than new clinical evidence.
Nothing in the record indicates a new indication, a safety communication or a change to how olanzapine should be prescribed. Its metabolic monitoring requirements are unchanged.
The applicant is an Indian manufacturer, but the record concerns the US market; any implication for products sold in India is unknown.
- No change to olanzapine prescribing follows from this listing.
- Continue baseline and periodic weight, glucose and lipid checks on olanzapine.
- The record does not state what the supplement changes.
- Its relevance to olanzapine supplied in India is unknown.
Why it matters
It shows the regulatory sweep at work, and confirms nothing has changed for prescribers of a widely used antipsychotic.
Don't overread it
A supplement to a generic application is not a new indication or a safety finding.
Read the rest in the app
You have read your two free briefings this month. The app carries all 27 specialties, every morning, free — and this finding is waiting in it.
Scan to keep reading on your phone. No account needed to start.
Tomorrow morning, before your first patient
One edition a day for psychiatry, written by the desk, every claim tied to its paper. Six minutes.
Get the app — free