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FDA label_change · 2022-10-21

FDA Approved: BYLVAY — Supplemental Application (Ipsen Biopharmaceuticals, Inc.)

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Summary

The document notes a supplemental application submission for BYLVAY (odevixibat) by Ipsen Biopharmaceuticals, Inc., related to labeling changes.

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Diseases / indications

Drugs mentioned

  • BYLVAY (odevixibat)

Snippet

SUPPL AP for BYLVAY (ODEVIXIBAT)