Le Lézard
Classified in: Health, Business
Subjects: LIC, FDA

Brand Institute Partners on Brand Name Development for FDA Approved Treatment for the Chronic Management of Urea Cycle Disorders (UCDs)


MIAMI, July 19, 2022 /PRNewswire/ -- Brand Institute is proud to announce its work with Duchesnay in developing the brand name PHEBURANE®.

PHEBURANE® (sodium phenylbutyrate) is indicated an adjunctive therapy to standard of care, which includes dietary management, for the chronic management of adult and pediatric patients with urea cycle disorders (UCDs), involving deficiencies of carbamylphosphate synthetase, ornithine transcarbamylase or argininosuccinic acid synthetase.

UCDs are rare genetic disorders that results in a deficiency of one of the six enzymes in the urea cycle. These enzymes are responsible for removing ammonia from the blood stream.

PHEBURANE® was approved by the FDA on June 17, 2022. PHEBURANE® is a registered trademark of Lucane Pharma.

"The entire Brand Institute and Drug Safety Institute team congratulates Duchesnay on the FDA approval for PHEBURANE," 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.

CONTACT:
James Dettore
Chairman & C.E.O.
[email protected]
www.brandinstitute.com

SOURCE Brand Institute, Inc.


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