FDA Bars Compounding of Semaglutide, Tirzepatide
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- FDA proposes to exclude semaglutide and tirzepatide from the list of substances eligible for large‑scale compounding, citing no clinical need.
- Novo Nordisk benefits as the FDA block prevents compounding of its semaglutide‑based Wegovy and Ozempic products.
- Eli Lilly gains protection for its tirzepatide‑based Mounjaro and Zepbound medicines from large‑scale compounding.
- Katherine Szarama named acting director of the Center for Biologics Evaluation and Research, taking over from Vinay Prasad.
- Vinay Prasad left the FDA on Thursday after a contentious tenure marked by controversial rare‑disease drug and vaccine rulings.
- Houman Hemmati was a top candidate for the acting director role, according to government and industry sources, but was not selected.
Why it matters: Not enough in the article to say why this matters.
