Radium Ra 223 Dichloride Injection: U.S. Food and Drug Administration Drug Approval Summary
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Radium Ra 223 dichloride injection: U.S. Food and Drug Administration drug approval summary.
On May 15, 2013, the U.S. Food and Drug Administration (FDA) approved radium Ra 223 dichloride (Ra-223; Xofigo injection; Bayer HealthCare Pharmaceuticals Inc.) for the treatment of patients with castration-resistant prostate cancer (CRPC), symptomatic bone metastases, and no known visceral metastatic disease. The FDA review was based on clinical trial BC1-06, which randomly allocated patients ...
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OnMay15, 2013, theU.S. FoodandDrugAdministration (FDA) approved radiumRa223dichloride (Ra223; Xofigo injection; Bayer HealthCare Pharmaceuticals Inc.) for the treatment of patients with castrationresistant prostate cancer (CRPC), symptomatic bone metastases, and no known visceral metastatic disease. The FDA reviewwas based on clinical trial BC1-06, which randomly allocated patients (2:1) to eit...
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ژورنال
عنوان ژورنال: Clinical Cancer Research
سال: 2013
ISSN: 1078-0432,1557-3265
DOI: 10.1158/1078-0432.ccr-13-2665