Posted by Michael Wonder on 01 Jun 2021
Novo Nordisk resubmits once weekly semaglutide 2 mg for the treatment of type 2 diabetes for US regulatory approval
29 May 2021 - Novo Nordisk today announced the resubmission of a label expansion application to the US FDA for the existing marketing authorisation for Ozempic, a once weekly glucagon-like peptide-1 analogue, to introduce a new dose of 2 mg.
The resubmission follows the refusal to file letter received by the FDA on 22 March 2021.
