Novo Nordisk
Novo Nordisk announced that the FDA issued a refusal-to-file letter related to its application to expand the label for once-weekly subcutaneous Ozempic (semaglutide).
The company had sought to expand the label for a 2.0-mg dose of once-weekly semaglutide to treat type 2 diabetes. It filed the letter on Jan. 20, 2021.
The letter indicates that FDA has concluded additional information is needed to review an application.
Get the full story from our sister site, Drug Delivery Business.
Filed Under: Metabolic disease/endicrinology
Tell Us What You Think!
You must be logged in to post a comment.