FDA Approves Orphalan's CUVRIOR™ (trientine tetrahydrochloride), the first treatment for Wilson's disease in over five decades
MIAMI, May 4, 2022 /PRNewswire/ -- Brand Institute is proud to announce working with rare disease specialist, Orphalan, in developing the brand name CUVRIOR™, approved by the United States Food and Drug Administration on April 28, 2022.
CUVRIOR™ is indicated for the treatment of adult patients with stable Wilson's disease who are de-coppered and tolerant to penicillamine. Wilson's disease is a rare genetic disorder that prevents the body from removing extra copper, causing copper to build up in the liver, brain, eyes, and other organs. Without treatment, high copper levels can cause life-threatening organ damage.
"The entire Brand Institute and Drug Safety Institute Team congratulates Orphalan on the FDA approval of CUVRIOR," 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.