Novo Nordisk Gets FDA Refusal to File Letter for Ozempic
The FDA has issued Novo Nordisk a Refusal to File letter over an expanded indication for its Ozempic (semaglutide) once-a-week 2 mg capsule for treating type 2 diabetes.
The Danish drugmaker, which filed the application for a label expansion at the end of January, says the FDA has determined that more information is required for its review.
The agency is seeking more data related to Novo Nordisk’s proposed new manufacturing facility, which it says needs to be included in a resubmitted application. The company expects to resubmit the application during the second quarter of this year.