Research ArticleSpecial Contributions

The Future of USP Monographs for PET Drugs

Sally Schwarz, Jeffrey Norenberg, Marc Berridge, Stephen Dragotakes, Joseph Hung, Jeanne Link, N. Scott Mason, Steve Mattmuller, Richard A. Nickel, Alan Packard, Justin Paolino, Neil Petry, James Ponto, Timothy M. Quinton, Katherine L. Seifert, Dennis Swanson, Ronald E. Weiner and Steven Zigler
Journal of Nuclear Medicine March 2013, 54 (3) 472-475; DOI: https://doi.org/10.2967/jnumed.112.115089

Article Figures & Data

Tables

  • TABLE 1

    PET Drugs with a USP Monograph but Not Approved by the FDA

    PET drug
    18F-fluorodopa injection
    11C-flumazenil injection
    11C-methionine injection
    11C-raclopride injection
    11C-sodium acetate injection
    11C-carbon monoxide injection
    11C-mespiperone injection
    15O-water injection
  • TABLE 2

    PET Drugs with a USP Monograph and an Approved NDA or ANDA (7)

    PET DrugApplication numberHolderApproval dateCurrent status
    13N-ammonia injectionNDA 22-119Feinstein InstituteAugust 23, 2007Active
    18F-fludeoxyglucose injectionNDA 20-306Downstate Clinical PET CenterAugust 19, 1994Discontinued
    NDA 21-768Weill Medical CollegeAugust 4, 2004Active
    NDA 21-870Feinstein InstituteAugust 19, 2005Active
    ANDA 79-086PETNET SolutionsFebruary 25, 2011Active
    18F-sodium fluoride injectionNDA 17-042GE HealthcareFebruary 24, 1972Discontinued
    NDA 22-494National Cancer InstituteJanuary 26, 2011Discontinued
    89Rb rubidium chloride injectionNDA 19-414BraccoDecember 29, 1989Active
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