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FDA Asks Novo Nordisk For More Information On Semaglutide Label Expansion Application

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The FDA has issued a Refusal to File letter covering Novo Nordisk A/S' (NYSE: NVO) label expansion application for once-weekly semaglutide 2.0 mg to treat type 2 diabetes, which was filed on 20 January.

  • The FDA has requested additional information in the letter, including data relating to a proposed new manufacturing site.
  • The company will resubmit the application to FDA during the second quarter of 2021.
  • Though there is a requirement for additional information for resubmission, Novo Nordisk believes the already completed trial program will be sufficient for approval of the label expansion application.
  • Price Action: NVO shares are trading 1.59% lower at $69.92 in premarket on the last check Tuesday.
 

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Posted-In: Type 2 DiabetesBiotech News Health Care FDA General

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