FDA Asks Novo Nordisk For More Information On Semaglutide Label Expansion Application

The FDA has issued a Refusal to File letter covering Novo Nordisk A/S' (NYSE: NVO) label expansion application for once-weekly semaglutide 2.0 mg to treat type 2 diabetes, which was filed on 20 January.

The FDA has requested additional information in the letter, including data relating to a proposed new manufacturing site.