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FLUDEOXYGLUCOSE F18

NDA

FLUDEOXYGLUCOSE F-18 | N020306 | DOWNSTATE CLINICAL PET CENTER

2 strengths0 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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
ABT Molecular Imaging, Inc. - Citizen Petition FDA-2012-P-0387 · 3 docket documents ABT Molecular Imaging, Inc. filed a suitability petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Fludeoxyglucose F18 Injection suitable for consideration in an ANDA with a reduced strength range of 1–20 mCi/mL End of Synthesis, compared	Other	2012-05-02	Granted	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

93 trials from ClinicalTrials.gov — 4 recruiting, 9 active, 51 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Triapine With Chemotherapy and Radiation Therapy in Treating Patients With IB2-IVA Cervical or Vaginal Cancer NCT02595879	Phase 1	Active	National Cancer Institute (NCI)	21	2019-09-18 → 2027-04-29
Testing the Addition of the Drug Atezolizumab to the Usual Radiation Treatment for Patients With Early Non-small Cell Lung Cancer NCT04214262	Phase 3	Active	National Cancer Institute (NCI)	415	2020-08-13 → 2027-06-09
Copper Cu 64-DOTA-Trastuzumab PET in Predicting Response to Treatment With Ado-Trastuzumab Emtansine in Patients With Metastatic HER2 Positive Breast Cancer NCT02226276	N/A	Active	City of Hope Medical Center	10	2015-01-07 → 2026-09-29
Lower-Dose Chemoradiation in Treating Patients With Early-Stage Anal Cancer, the DECREASE Study NCT04166318	Phase 2	Active	ECOG-ACRIN Cancer Research Group	252	2020-01-02 → 2029-12-31
Entinostat in Combination With Aldesleukin in Treating Patients With Metastatic Kidney Cancer NCT01038778	Phase 1/2	Active	National Cancer Institute (NCI)	47	2009-10-29 → 2027-02-12
De-intensified Radiation Therapy With Chemotherapy (Cisplatin) or Immunotherapy (Nivolumab) in Treating Patients With Early-Stage, HPV-Positive, Non-Smoking Associated Oropharyngeal Cancer NCT03952585	Phase 2/3	Active	National Cancer Institute (NCI)	384	2019-10-09 → 2026-12-11
Testing Immunotherapy Versus Observation in Patients With HPV Throat Cancer NCT03811015	Phase 3	Active	National Cancer Institute (NCI)	636	2019-08-16 → 2027-01-01
PET/MRI Scan for the Evaluation of Resectable Stage IA1-IB3 Cervical Cancer NCT04219904	Early Phase 1	Active	M.D. Anderson Cancer Center	25	2018-09-07 → 2027-09-30
Using FDG-PET/CT to Assess Response of Bone-Dominant Metastatic Breast Cancer, FEATURE Study NCT04316117	Phase 2	Active	ECOG-ACRIN Cancer Research Group	138	2020-09-15 → 2027-08-31
PET/MRI, 18F-FDG PET/CT and Whole Body MRI in Finding Extramedullary Myeloid Leukemia in Patients With Newly Diagnosed Acute Myeloid Leukemia NCT02390635	Phase 1	Recruiting	M.D. Anderson Cancer Center	77	2020-07-15 → 2027-09-15

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

API Supply Chain0 active DMFs2 inactive

0 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

INSTITUTE CLINICAL PETInactiveFLUDEOXYGLUCOSE F-18 INJECTION

DMF 90571991

GENERAL ELECTRIC MEDICAL SYSTEMSInactiveFLUDEOXYGLUCOSE F-18 INJECTION

DMF 132681998

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Mar 10, 2004	SUPPL -5	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 4-40mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Aug 19, 1994

No patent or exclusivity listings for this strength.

#002 — 4-90mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Sep 25, 2001