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FDA approval · 2023-02-28

FDA Approved: SKYCLARYS — Original Application (Biogen)

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Summary

FDA approved SKYCLARYS (omaveloxolone) from Biogen under Original Application NDA216718 for the treatment of Friedreich's ataxia.

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Diseases / indications

Drugs mentioned

  • SKYCLARYS (omaveloxolone)

Snippet

ORIG AP for SKYCLARYS (OMAVELOXOLONE)