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
Ref: GlobeNewswire | Image: Energy Watch
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