Approval of Radiopharmaceutical 'Prostaview Injection' for Prostate Cancer Diagnosis
Approved as the 43rd Domestically Developed New Drug by the Ministry of Food and Drug Safety
The Ministry of Food and Drug Safety announced on May 4 that it had approved the domestically developed new drug "Prostaview Injection (Florastamine (18F))" on April 30.
As a result, Prostaview Injection has been designated as the "43rd new drug developed in Korea."
This drug is a radiopharmaceutical used for lesion diagnosis in prostate cancer patients. It selectively binds to the prostate-specific membrane antigen (PSMA), which is highly expressed in prostate cancer, to detect lesions.
According to the "New Drug Product Approval and Review Process Guidelines" established last year, the Ministry formed a product-specific team and completed the approval process by prioritizing clinical trial (GCP) and manufacturing/quality control (GMP) reviews, as well as holding tailored face-to-face meetings.
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An official from the Ministry stated, "We expect that this drug will help establish accurate treatment directions for patients with recurrent or metastatic prostate cancer who have shown abnormal findings in existing imaging tests."
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