Novo Nordisk resubmits once-weekly semaglutide 2.0 mg for the treatment of type 2 diabetes for US regulatory approval | Proteins and Peptides
Hits: 239 BAGSVAERD, Denmark I May 28, 2021 I Novo Nordisk today announced the resubmission of a label expansion application to the US Food and Drug Administration (FDA) for the existing marketing authorisation for Ozempic ®, a once-weekly glucagon-like peptide-1 (GLP-1) analogue, to introduce a new dose of 2.0 mg. The resubmission follows the Refusal to File letter received by the FDA on 22 March 2021. The standard review time by the FDA is 10 months. About Novo Nordisk Novo Nordisk is a...
Source: pipelinereview.com