FDA approves Bayer radium-223 chloride expanded access program

LONDON, UK (Press Release) PBR/Pharmaceutical Business Review - February 3, 2012 - Bayer HealthCare has received the US Food and Drug Administration approval to proceed with its expanded access program for the investigational drug radium-223 chloride.

Expanded access refers to the use of an investigational drug, under certain circumstances, to treat patients with a serious disease or condition who cannot participate in a controlled clinical trial.

Radium-223 chloride is the investigational drug developed for patients diagnosed with castration-resistant prostate cancer (CRPC)/hormone-refractory prostate cancer (HRPC) with symptomatic bone metastases.

Radium-223 chloride will be made available to patients through qualified clinical sites participating in this program, the company said.



PBR/Pharmaceutical Business Review


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