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

March 23, 2021 Auto Bot Novo Nordisk, regulatory, semaglutide, Treat, Type 2 Diabetes 0

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

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