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FDA approval · 2015-11-06

FDA Approved: XTANDI — Supplemental Application (Astellas Pharma US, Inc.)

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Summary

FDA approved a supplemental NDA for XTANDI (enzalutamide) submitted by Astellas Pharma US, Inc., to update the labeling and/or expand an indication.

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Diseases / indications

Drugs mentioned

  • Xtandi (enzalutamide)

Snippet

SUPPL AP for XTANDI (ENZALUTAMIDE)