Novo Nordisk slammed with an RTF as the FDA raises CMC issues
Novo Nordisk’s blockbuster diabetes drug Ozempic (semaglutide) has already made the Danish drugmaker billions of dollars, and the company is aiming to capitalize on that success by expanding into higher doses and other indications like obesity and NASH. But late Monday the FDA told Novo: “Not so fast.”
US regulators slammed Novo with an RTF letter for a once-weekly semaglutide injection at the 2 mg dosing level, double the current highest-approved dose of the drug, for type 2 diabetes. According to Novo’s announcement, the FDA wanted to see more information regarding a proposed new manufacturing site.
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