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FDA label_change · 2018-08-31

FDA Approved: XOFIGO — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)

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Summary

FDA supplemental application for XOFIGO (radium-223 dichloride) submitted by Bayer HealthCare Pharmaceuticals Inc. to support changes to the labeling.

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Diseases / indications

Drugs mentioned

  • Xofigo (radium-223 dichloride)

Snippet

SUPPL AP for XOFIGO (RADIUM RA 223 DICHLORIDE)