Benzinga | May 28, 2021 12:04PM EDT

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

* Novo Nordisk A/S (NYSE: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.