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Radicava ORS FDA Approval History

Last updated by Judith Stewart, BPharm on June 7, 2022.

FDA Approved: Yes (First approved May 12, 2022)
Brand name: Radicava ORS
Generic name: edaravone
Dosage form: Oral Suspension
Company: Mitsubishi Tanabe Pharma Corporation
Treatment for: Amyotrophic Lateral Sclerosis

Radicava ORS is a free radical scavenger indicated for the treatment of amyotrophic lateral sclerosis (ALS).

  • Radicava ORS is an oral suspension formulation of edaravone. Radicava (edaravone) injection for intravenous infusion was first approved by the FDA for the treatment of amyotrophic lateral sclerosis in 2017.
  • Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease. Radicava ORS works as a free radical scavenger to relieve the effects of oxidative stress, a likely factor in the onset and progression of amyotrophic lateral sclerosis.
  • Radicava ORS is administered orally or via feeding tube in the morning after overnight fasting. The initial treatment cycle requires daily dosing for 14 days followed by a 14- day drug-free period. Subsequent treatment cycles require daily dosing for 10 days out of 14- day periods, followed by 14-day drug-free periods.
  • Warnings and precautions associated with Radicava ORS include hypersensitivity reactions and sulfite allergic reactions.
  • Common adverse reactions include contusion, gait disturbance, and headache.

Development timeline for Radicava ORS

Mar 23, 2023Enrollment Completion for Global, Phase 3b Study of RADICAVA ORS in ALS
May 13, 2022Approval FDA Approves Radicava ORS (edaravone) for the Treatment of Amyotrophic Lateral Sclerosis (ALS)

Further information

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