FDA
approval
· 2015-11-06
FDA Approved: XTANDI — Supplemental Application (Astellas Pharma US, Inc.)
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
Snippet
SUPPL AP for XTANDI (ENZALUTAMIDE)