Novo Nordisk Receives the US FDA’s Refusal to File Letter for Semaglutide to Treat T2D

 Novo Nordisk Receives the US FDA’s Refusal to File Letter for Semaglutide to Treat T2D

Novo Nordisk Receives the US FDA’s Refusal to File Letter for Semaglutide to Treat T2D

Shots:

  • The US FDA has issued refusal to file a letter covering the label expansion application for semaglutide (2.0mg/qw) for T2D, which was submitted on Jan 20, 2021
  • The US FDA has requested additional information including data relating to new manufacturing site
  • Novo Nordisk plans to resubmit the application to FDA in Q2’21

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: Energy Watch

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

Related post