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

  Ref: Globe Newswire | Image: Scrip- Informa PLC