FDA issues refusal to file letter for Novo Nordisk’s once-weekly semaglutide 2mg injection

The application, filed on 20 January 2021, was seeking an expanded approval for once-weekly semaglutide 2.0mg for the treatment of type 2 diabetes. In a statement, Novo said that the FDA has requested additional information. In UK, current maximum dose is 1 mg once weekly.

Source:

PharmaTimes