Novo Nordisk Resubmits Label Expansion Application to the US FDA for Semaglutide (2.0mg)

May 31, 2021 Auto Bot FDA, Novo Nordisk, regulatory, semaglutide 0

Shots:

  • The company has announced the resubmission of a label expansion application to the US FDA for the existing marketing authorization for Ozempic to introduce a new dose of 2.0mg for the Treatment of T2D
  • The resubmission follows the Refusal to File letter received by the FDA on 22 March 2021. The standard review time by the FDA is 10mos.
  • The company has submitted the label expansion application in Jan’2021, based on the P-III results that showed a significant decline in HbA1c compared to semaglutide (1.0mg) in patients with T2D

Click here to­ read full press release/ article | Ref: Globe Newswire | Image: Scrip- Informa PLC

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