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LOCAMETZ (nda215841)- (N/A)

GALLIUM GA-68 GOZETOTIDE NOVARTIS
N/A
No Yes
2036-Mar-09 Expired
None 2025-Mar-23
None No
LOCAMETZ, after radiolabeling with gallium-68, is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA)-positive lesions in men with prostate cancer: • with suspected metastasis who are candidates for initial definitive therapy. • with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. • for selection of patients with metastatic prostate cancer, for whom lutetium Lu 177 vipivotide tetraxetan PSMA-directed therapy is indicated.
0 0 0
Total Other Developers None
Drugs with Suitability No
N/A ** ** - - -
NDA Sales Available Total Generic Sales Available
Yes 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country

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Brand Name Generic Name Strength Dosage Route of Administration Innovator ParaIV

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