The decision covers Ozempic, Wegovy, Mounjaro and Zepbound, and represents a setback for the Outsourcing Facilities Association, which represents larger drug compounders that mix their own preparations, Bloomberg Law reports. The group argued that the FDA mishandled the process and failed to consider sufficient evidence.
FDA wins GLP‑1 dispute – setback for makers of copycat drugs
A U.S. federal appeals court has ruled that the FDA followed the correct procedure when the agency determined that Novo Nordisk’s and Eli Lilly’s diabetes and obesity drugs were no longer in a shortage situation.
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