RADICAVA

批准信原文要点

This “Changes Being Effected” sNDA provides alignment of the labeling for NDA 209176 with the labeling for Radicava ORS (edaravone oral suspension), 105 mg/5 mL, which was approved on May 12, 2022, under NDA 215446.

批准信原文要点

This Prior Approval supplemental new drug application updates sections 8 (Use in Specific Populations) and 12.3 (Pharmacokinetics) of the Radicava prescribing information with the study results from PMR-3208-3, as well as the following clinical studies conducted under IND 126396: MCI-186-J22 ... renal impairment ... MCI-186-J23 ... hepatic impairment ... MCI-186-E05 ... severe hepatic impairment. In addition, this supplement proposes to update section 12.2 (Pharmacodynamics) of the prescribing information to add the following statement as requested in the Agency’s January 24, 2020, PMR Fulfilled

批准信原文要点

This “Changes Being Effected” supplemental new drug application provides for correction of the infusion rate (mL per minute) error introduced into the Prescribing Information with the change from Radicava 30 mg/100 mL IV bags to Radicava 60 mg/100 mL IV bags, approved on Novem…

批准信原文要点

This Prior Approval supplemental new drug application provides for the addition of a more concentrated parenteral solution formulation for the drug product Radicava (edaravone) Injection containing 60 mg of edaravone per 100 mL.

批准信原文要点

This new drug application provides for the use of Radicava (edaravone) injection 30 mg/100 mL for the treatment of amyotrophic lateral sclerosis (ALS).