On 14 October the FDA recorded a supplement to an abbreviated new drug application for generic olanzapine (ANDA 210022) held by Cadila Pharmaceuticals, an Indian manufacturer. Supplements to generic applications usually cover manufacturing, labelling or packaging changes.
The record does not describe the content of the change, and nothing in it signals a new safety concern or a new indication for olanzapine. Prescribing and monitoring advice is unchanged.
- No change to olanzapine prescribing or monitoring follows from this record.
- Continue metabolic monitoring — weight, glucose and lipids — as standard for olanzapine.
- Report suspected adverse effects of any generic antipsychotic through the national pharmacovigilance programme.
Why it matters
Indian manufacturers supply much of the world's generic antipsychotics, so their US filings are worth tracking — but most are housekeeping.
Don't overread it
A supplement to a generic application is administrative, not a safety finding or a new indication.
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