FDAnews Drug Daily Bulletin

Novo Nordisk will have to wait until late October to get word on the fate of two ultra-long-acting insulin treatments because the FDA needs additional time to review data clarifications and analyses it requested after the initial NDA submissions. The Danish drugmaker submitted a “substantial” amount of new data, and due to the size and timing of the submissions the agency considers them major amendments to the marketing applications, Novo Nordisk said.
Washington Drug Letter