FDA Alerts
FDA Approves New Rx, Xofigo
The US Food and Drug Administration today approved Xofigo (radium Ra 223 dichloride) to treat men with symptomatic late-stage (metastatic) castration-resistant prostate cancer that has spread to bones but not to other organs.
FDA Expands Zytiga’s use for Late-Stage Prostate Cancer
The US Food and Drug Administration today expanded the approved use of Zytiga (abiraterone acetate) to treat men with late-stage (metastatic) castration-resistant prostate cancer prior to receiving chemotherapy.
FDA Approves Prostate Cancer Imaging Agent
The US Food and Drug Administration approved the production and use of Choline C 11 Injection, a positron emission tomography (PET) imaging agent used to help detect recurrent prostate cancer.
FDA Approves Prolia for osteoporosis
On September 16, 2011, the U.S. Food and Drug Administration granted approval for denosumab ( Prolia , Amgen Inc.) as a treatment to increase bone mass in patients at high risk for fracture receiving androgen deprivation therapy (ADT) for nonmetastatic prostate cancer or adjuvant aromatase inhibitor (AI) therapy for breast cancer. In men with nonmetastatic prostate cancer, denosumab also reduced the incidence of vertebral fracture.
FDA Drug Safety Communication: 5-alpha reductase inhibitors (5-ARIs)
The U.S. Food and Drug Administration (FDA) is informing healthcare professionals that the Warnings and Precautions section of the labels for the 5-alpha reductase inhibitor (5-ARI) class of drugs has been revised to include new safety information about the increased risk of being diagnosed with a more serious form of prostate cancer (high-grade prostate cancer).
FDA approves Zytiga for late-stage prostate cancer
The U.S. Food and Drug Administration (FDA) today approved Zytiga ( abiraterone acetate) in combination with prednisone (a steroid) to treat patients with late-stage (metastatic) castration-resistant prostate cancer who have received prior docetaxel (chemotherapy).