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GALLIUM GA 68 GOZETOTIDE

NDA

GALLIUM GA-68 GOZETOTIDE | N212643 | UNIV OF CALIFORNIA SAN FRANCISCO

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

4 trials from ClinicalTrials.gov, 3 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
68Ga-PSMA-11 PET/CT in Imaging Patients With Intermediate or High Risk Prostate Cancer Before Surgery NCT03368547	N/A	Completed	Jonsson Comprehensive Cancer Center	400	2016-12-12 → 2021-06-18
Gallium Ga 68-labeled PSMA-11 PET/CT in Detecting Recurrent Prostate Cancer in Patients After Initial Therapy NCT02940262	Phase 3	Completed	Jonsson Comprehensive Cancer Center	1,138	2016-09-15 → 2021-06-18
PSMA PET/MRI or PSMA PET/CT for Evaluation of Liver Cancer NCT04310540	Early Phase 1	Completed	Mayo Clinic	42	2020-06-05 → 2023-11-02
Effect of Androgen Receptor Signaling Inhibitors on 68Ga-PSMA-11 PET/CT Imaging in Patients With Castration-Resistant Prostate Cancer NCT04279561	Phase 1	Terminated	Jonsson Comprehensive Cancer Center	9	2020-04-16 → 2022-09-15

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Nov 18, 2021	SUPPL -1	View Letter (PDF)
Dec 2, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.5-5mCi/mL

RLDAP

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Dec 1, 2020

No patent or exclusivity listings for this strength.