OSILODROSTAT PHOSPHATE | N212801 | RECORDATI RARE DISEASES INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Annora Pharma Private Limited FDA-2026-P-4574 · 2 docket documents Annora Pharma Private Limited filed this citizen petition requesting that the FDA determine whether ISTURSIA (osilodrostat) tablets 10 mg, NDA 212801, held by Recordati Rare Diseases Inc., was voluntarily withdrawn from the commercial market for reasons of safety or efficacy, as the drug is currentl | 505(q) | 2026-04-24 | Open | Annora Pharma Private Limited |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Code | Date | Status |
|---|---|---|
| ODE-286 | Mar 6, 2027 | < 1 year |
| ODE-535 | Apr 15, 2032 | Active |