Xofigo Injection Recommended for Approval in EU

New Drug Approvals

Cl 223Ra Cl

is the structure

http://www.ama-assn.org/resources/doc/usan/radium-ra-223-dichloride.pdf  check out yourself

Xofigo® (radium Ra 223 dichloride) Injection Recommended for Approval in the European Union

Oslo, Norway, 20 September 2013 – Algeta ASA (OSE: ALGETA), announced today that Bayer has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommending approval of Xofigo® (radium Ra 223 dichloride) in Europe. The proposed indication is for the treatment of adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases. The decision of the European Commission (EC) on the approval is expected in the fourth quarter of 2013.

Xofigo® (radium Ra 223 dichloride) injection was approved by the US Food and Drug Administration (FDA) in May 2013 for the treatment of patients with CRPC, symptomatic bone metastases and no known visceral metastatic disease and is now available in the United States at…

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