GALLIUM GA-68 EDOTREOTIDE | N210828 | UNIV IOWA HOSPS AND CLINICS PET IMAGING CENTER
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Curium US LLC FDA-2026-P-1222 · 21 docket documents Curium US LLC filed this citizen petition under 21 C.F.R. §§ 10.30 and 10.31 and section 505(q) of the FDC Act requesting that the FDA refuse to approve Lantheus Holdings' NDA for Gallium-68 edotreotide injection (Ga-68 DOTATOC) unless Lantheus submits data demonstrating the kit's compatibility with | 505(q) | 2026-02-03 | Denied | Curium US LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Code | Date | Status |
|---|---|---|
| ODE-383 | Aug 21, 2026 | < 1 year |
| W | Aug 21, 2026 | < 1 year |