Novo Nordisk: stock down after FDA snub
(CercleFinance.com) - The Novo Nordisk share is down over 2% on the OMX after the FDA rejected a label extension application for semaglutide 2.
0 mg once weekly for the treatment of type 2 diabetes, which was filed on 20 January.
In its rejection letter, the US health authority requested additional information, including data on a proposed new manufacturing site, the Danish pharmaceutical company said.
Believing that the already completed clinical trial programme will be sufficient for approval of its application, Novo Nordisk plans to resubmit its application to the FDA, with additional information, in the second quarter of 2021.
Copyright (c) 2021 CercleFinance.com. All rights reserved.
0 mg once weekly for the treatment of type 2 diabetes, which was filed on 20 January.
In its rejection letter, the US health authority requested additional information, including data on a proposed new manufacturing site, the Danish pharmaceutical company said.
Believing that the already completed clinical trial programme will be sufficient for approval of its application, Novo Nordisk plans to resubmit its application to the FDA, with additional information, in the second quarter of 2021.
Copyright (c) 2021 CercleFinance.com. All rights reserved.