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FDA Approves RADICAVA ORS® (edaravone) Oral Suspension for the Treatment of Amyotrophic Lateral Sclerosis (ALS) by Mitsubishi Tanabe
News provided byBrand Institute, Inc.
May 26, 2022, 12:16 PM ET
MIAMI, May 26, 2022 /PRNewswire/ -- Brand Institute is proud to announce working with Mitsubishi Tanabe in developing the brand name Radicava ORS®, approved by the Food and Drug Administration (FDA) on May 12, 2022. FDA approved Radicava ORS (edaravone) oral suspension for the treatment of amyotrophic lateral sclerosis (ALS). Radicava ORS is an orally administered version of Radicava, which was originally approved in 2017 as an intravenous (IV) infusion to treat ALS, commonly referred to as Lou Gehrig's disease.
After fasting overnight, Radicava ORS should be taken in the morning orally or via feeding tube. The oral medication has the same dosing regimen as Radicava for intravenous infusion—an initial treatment cycle of daily dosing for 14 days, followed by a 14-day drug-free period and subsequent treatment cycles consisting of daily dosing for 10 out of 14-day periods, followed by 14-day drug-free periods.
"The entire Brand Institute and Drug Safety Institute Team congratulates Mitsubishi Tanabe on the FDA approval of Radicava ORS," said Brand Institute's Chairman and C.E.O., James L. Dettore.
About Brand Institute and our wholly owned regulatory subsidiary, Drug Safety Institute
Brand Institute is the global leader in pharmaceutical and healthcare-related name development, with a portfolio of over 3,800 marketed healthcare brand names, 1,200 USAN/INN nonproprietary names for 1,100 clients. The company partners on over 75% of pharmaceutical brand and nonproprietary name approvals globally every year with healthcare manufacturers. Drug Safety Institute is composed of former naming regulatory officials from global government health agencies, including Food and Drug Administration (FDA), European Medicines Agency (EMA), Health Canada (HC), American Medical Association (AMA), and the World Health Organization (WHO). These regulatory experts co-authored the name review guidelines while with their respective agencies, with many responsible for ultimately approving (or rejecting) brand name applications. Now working for a private company, these professionals provide Brand Institute's clients with industry-leading guidance pertaining to drug name safety (i.e., preventing medication errors), packaging, and labeling.
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SOURCE Brand Institute, Inc.