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

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

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

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

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

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