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May 12, 2022 – Radicava ORS® (edaravone – Mitsubishi Tanabe Pharma America), has received FDA approval to treat amyotrophic lateral sclerosis (ALS) in adults.

  • This action converts a conditional accelerated approval for the indication into full approval.
  • Recommended dosing for Radicava ORS is 105mg (5mL) administered by mouth or via feeding tube. The medication is taken in the morning after overnight fasting. For one hour following administration, patients should consume no food and should only drink water.
  • Administration of both Radicava and Radicava ORS follows the following schedule:
    • Initial treatment cycle: Daily dosing for 14 days followed by a 14-day drug-free period.
    • Subsequent treatment cycles: Daily dosing for 10 days out of each 14-day period, followed by 14-day drug-free periods.
    • Administration of both Radicava and Radicava ORS follows the following schedule:
  • The wholesale acquisition cost of Radicava ORS is $12,719.30 per 28-day supply.