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Radicava FDA Approval History

FDA Approved: Yes (First approved May 5, 2017)
Brand name: Radicava
Generic name: edaravone
Dosage form: Injection
Company: Mitsubishi Tanabe Pharma
Treatment for: Amyotrophic Lateral Sclerosis

Radicava (edaravone) is a free radical scavenger that relieves the effects of oxidative stress, a likely factor in the onset and progression of amyotrophic lateral sclerosis.

Development timeline for Radicava

May 13, 2022Approval FDA Approves Radicava ORS (edaravone) for the Treatment of Amyotrophic Lateral Sclerosis (ALS)
May  5, 2017Approval FDA Approves Radicava (edaravone) to Treat Amyotrophic Lateral Sclerosis (ALS)
Aug 30, 2016FDA Accepts Mitsubishi Tanabe Pharma's NDA Filing for Edaravone to Treat ALS
Jun 22, 2016Mitsubishi Tanabe Pharma Submits New Drug Application for Edaravone to Treat ALS in the United States

Further information

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