RadioMedix has received FDA approval for gallium Ga 68 gozetotide injection, also known as Ga-68 PSMA-11, through an Abbreviated New Drug Application.
The diagnostic radiopharmaceutical targets prostate-specific membrane antigen for PET imaging in patients with prostate cancer. RadioMedix described the product as a generic Ga-68 PSMA-11 radiodiagnostic.
FDA labeling for gallium Ga 68 gozetotide injection lists PET imaging of PSMA-positive lesions in men with prostate cancer. The indication includes patients with suspected metastasis who are candidates for initial definitive therapy and patients with suspected recurrence based on elevated PSA level.
The approval was linked to an FDA inspection of RadioMedix’s SPICA Center, a radiopharmaceutical manufacturing site north of Houston. RadioMedix said the inspection ended with no Form 483 observations.
SPICA Center is a 27,500-sq-ft facility with multiple clean rooms, quality control suites, quality assurance systems, and 21 CFR 211 compliance, according to the company.
RadioMedix said the site supports development and production of targeted diagnostic and therapeutic radiopharmaceuticals for internal programs and external partners.
Ga-68 PSMA-11 binds to PSMA, a protein commonly expressed in prostate cancer. The FDA label notes that increased uptake is not specific for prostate cancer and that image interpretation requires clinical correlation.
Company:RadioMedix
Sources
- Gallium Ga 68 Gozetotide Injection prescribing information. Regulatory filing
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