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CERIANNA

NDA

FLUOROESTRADIOL F-18 | N212155 | GE HEALTHCARE

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

2 trials from ClinicalTrials.gov, 2 active

Trial	Phase	Status	Sponsor	Enrollment	Dates
Serial FES PET/CT to Measure Hormone Expression in Patients Undergoing Endocrine Targeted Therapy NCT04692103	Phase 2	Active	University of Washington	2	2021-07-10 → 2041-04-30
FES PET/CT in Predicting Response in Patients With Newly Diagnosed Metastatic Breast Cancer Receiving Endocrine Therapy NCT02398773	Phase 2	Active	National Cancer Institute (NCI)	99	2016-05-04 → 2026-12-31

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
May 7, 2024	SUPPL -21	View Letter (PDF)
May 22, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 50ML (4-100mCi/ML)

RLD

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: May 20, 2020

No patent or exclusivity listings for this strength.