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