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AMMONIA N 13

NDA

AMMONIA N-13 | N022119 | FEINSTEIN INSTITUTE MEDICAL RESEARCH

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

3 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from PETNET Solutions, Inc. FDA-2023-P-2729 · 6 docket documents PETNET Solutions, Inc. filed a suitability petition on June 20, 2023, requesting approval of a Prior Approval Supplement to ANDA 204510 for Ammonia N 13 Injection, a PET drug approved under NDA 022119, to increase the strength from 3.75-37.5 mCi/mL End of Synthesis to 3.75-240 mCi/mL End of Synthesi	Suitability	2023-07-03	Withdrawn	PETNET Solutions, Inc.
Feinstein Institute for Medical Reseach, North Shore-LIJ Health System - Citi... FDA-2012-P-0103 · 5 docket documents Thomas Chaly, Ph.D., representing The Feinstein Institute for Medical Research/North Shore-LIJ Health System, submitted this citizen petition under section 505(j)(2)C of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare a proposed generic drug product suitable for consideratio	Other	2012-02-03	Granted	—
Precision Nuclear, LLC - Citizen Petition FDA-2011-P-0337 · 5 docket documents Precision Nuclear, LLC, represented by Jon L. McReynolds, PharmD, filed this section 505(j)(2)(C) citizen petition on May 5, 2011, requesting that the FDA declare Ammonia [N-13] Injection suitable for consideration in an Abbreviated New Drug Application (ANDA) referencing NDA 022119 with a proposed	Other	2011-05-16	Granted	—

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

Clinical Trials

8 trials from ClinicalTrials.gov — 2 recruiting, 5 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Safety of PET MPI Using the CRCHUM N-13 Ammonia NCT03275584	Phase 4	Recruiting	Centre hospitalier de l'Université de Montréal (CHUM)	20,000	2018-01-30 → 2028-01
Molecular Imaging of Primary Amyloid Cardiomyopathy NCT02641145	N/A	Recruiting	Brigham and Women's Hospital	171	2016-04-01 → 2028-12-31
Distribution of Rubidium-82, Nitrogen-13 Ammonia, and Fluorine-18 Fluorodeoxyglucose in Normal Volunteers NCT01433705	Phase 1	Completed	University of Michigan	70	2011-11 → 2018-01-19
PET/CT-Assessment of Liver Tumor Ablation NCT02018107	N/A	Completed	Dana-Farber Cancer Institute	33	2014-01 → 2019-02-16
Spironolactone Therapy in Chronic Stable Right HF Trial NCT03344159	Phase 4	Completed	Ottawa Heart Institute Research Corporation	15	2018-04-01 → 2024-05-01
Myocardial Blood Flow by PET and N-13 Ammonia During Regadenoson vs Adenosine Stress NCT01370265	N/A	Completed	Mayo Clinic	12	2011-02 → 2012-06
Pilot Study to Evaluate Right Ventricular Function With Riociguat in CTEPH NCT02094001	Phase 2	Completed	Ottawa Heart Institute Research Corporation	6	2014-05 → 2016-06
A Pilot Study Evaluating Heart and Lung Metabolism in Pulmonary Hypertension Associated With Left Heart Disease NCT02237378	N/A	Terminated	Ottawa Heart Institute Research Corporation	2	2014-12 → 2018-08

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Jan 7, 2011	SUPPL -1	View Letter (PDF)
Aug 27, 2007	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 30mCi-300mCi/8ML (3.75-37.5mCi/ML)

RLDAP

0 patents0 exclusivities▴

INJECTABLE;INTRAVENOUS | Approved: Aug 23, 2007

No patent or exclusivity listings for this strength.