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

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Summary

FDA approves Orfadin (nitisinone) through the original NDA (NDA206356). The approval supports its use for hereditary tyrosinemia type I.

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Diseases / indications

• Tyrosinemia Type

Drugs mentioned

• Orfadin (nitisinone)

Snippet

ORIG AP for ORFADIN (NITISINONE)