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FDA approval · 2017-09-01

FDA Approved: ORFADIN — Supplemental Application (Swedish Orphan Biovitrum AB (publ))

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Summary

The FDA approved a supplemental application for Orfadin (nitisinone) submitted by Swedish Orphan Biovitrum AB (publ), updating the product labeling.

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Diseases / indications

Drugs mentioned

  • Orfadin (nitisinone)

Snippet

SUPPL AP for ORFADIN (NITISINONE)