biotech / news / / STAT
The FDA has proposed excluding the active ingredients in wildly popular obesity and diabetes drugs from a list of substances that can be used for making certain compounded versions.
The FDA proposed excluding semaglutide and tirzepatide from allowed substances for large-scale compounding.
KEY POINTS
- The FDA found no clinical need for 503B facilities to compound semaglutide or tirzepatide drugs.
- 503B compounders can no longer legally market compounded versions of Wegovy, Ozempic, Moujaro, or Zepbound.
- This move favors Novo Nordisk and Eli Lilly by restricting alternative supply from large compounders.
COMPANIES
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