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Treats amyotrophic lateral sclerosis (ALS). NDA 215446, held by Shionogi. Edaravone.
As of Nov 15, 2026, NDA 215446 (Radicava Ors), held by Shionogi, was first approved by FDA on May 12, 2022, with 0 approved supplements and 0 published complete response letters.
First approved: May 12, 2022
Review: Priority
Supplements approved: 0
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
RADICAVA and RADICAVA ORS are indicated for the treatment of amyotrophic lateral sclerosis (ALS). RADICAVA and
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters.Drugs@FDA and FDA complete response letters
