All regulations
Nonrulemaking
FDA
Open for Comments
FDA-2025-P-4282
Requests that the FDA take administrative action to issue an additional indication for clozapine, an existing prescription medicine and add a third indication to labeling of all clozapine products.
Documents
41
Comments
142
Key Dates
Comment Period OpensSep 25, 2025
Documents
| Type | Title | Status |
|---|---|---|
Other |
Comment Statistics
Total Comments
142
Keywords
CDER
Citizen Petition
take administrative action to
issue an additional indication for clozapine an
existing prescription medicine and add a third
indication to labeling of all clozapine products
OPEN
Data from Regulations.gov