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