Novo Nordisk Resubmits Semaglutide 2mg For Type 2 Diabetes In US

by Vandana Singh, Benzinga Editor

May 28, 2021 12:04 PM | 1 min read | Make a Comment

Novo Nordisk A/S NVO has resubmitted a label expansion application to FDA for Ozempic (semaglutide) to introduce a new dose of 2.0 mg.
Semaglutide is a glucagon-like peptide-1 (GLP-1) analog.
The Type 2 diabetes injection is currently approved at 0.5-mg and 1-mg doses given once a week.
The resubmission follows the Refusal to File letter received by the FDA in March.
The agency was looking for additional information about a proposed new manufacturing site. The company said that the already-completed clinical trial program would be sufficient to approve the label expansion application.
The standard review time by the FDA is ten months.
Price Action: NVO shares are up 0.34% at $79.09 during the market session on the last check Friday.