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Novo Nordisk Urges FDA to Ban Compounded Versions of Ozempic and Wegovy

The pharmaceutical company argues that compounded semaglutide poses significant safety risks due to its complexity.

A combination image shows an injection pen of Zepbound, Eli Lilly's weight loss drug, and boxes of Wegovy, made by Novo Nordisk. REUTERS/Hollie Adams/Brendan McDermid/Combination/File Photo
A view shows the logo of Novo Nordisk at the company's office in Bagsvaerd, on the outskirts of Copenhagen, Denmark, March 8, 2024. REUTERS/Tom Little/File Photo
Senate Health, Education, Labor, and Pensions Committee Chairman Bernie Sanders (I-VT) delivers opening remarks during a hearing about drug pricing on Sep. 24.
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Overview

  • Novo Nordisk has requested the FDA to add semaglutide to its 'Demonstrable Difficulties for Compounding Lists,' which would prevent pharmacies from producing compounded versions of the drug.
  • The company cites safety concerns, including impurities and incorrect dosages, as reasons for the ban on compounded versions of its drugs Ozempic and Wegovy.
  • Compounded semaglutide has become popular due to shortages and high costs of the branded drugs, with compounded versions offering a more affordable alternative.
  • The FDA has yet to make a decision on the request, but has acknowledged potential risks associated with compounded GLP-1 drugs like semaglutide.
  • Novo Nordisk's action is part of a broader legal effort to curb the production and sale of unapproved versions of its weight loss and diabetes medications.