The pharmaceutical company argues that the active ingredient in both drugs, semaglutide, is too complex for compounders to safely replicate. The move follows Novo Nordisk’s yearlong battle against clinics and pharmacies that manufacture and sell cheaper, unapproved versions of semaglutide amid shortages of the branded drugs in the U.S.
While compounded alternatives provide a more affordable option, Novo Nordisk warns of risks such as unknown impurities and incorrect dosages in unregulated versions.
The FDA is reviewing the petition and has previously issued warnings about the potential dangers of compounded GLP-1 medications such as semaglutide. The agency will decide whether to add semaglutide to the list of drugs that are too complicated for compounding even in a time of shortage, the report said.
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