US FDA issues complete response on Amgen's Prolia with July action date
The US Food and Drug Administration has evaluated the content of biotechnology major Amgen's Complete Response submission for Prolia (denosumab) in the treatment of postmenopausal osteoporosis and classified it as a Class 2 resubmission, has set a corresponding Prescription Drug User Fee Act (PDUFA) action date of July 25, 2010.
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