Friday, July 16, 2021

FDA refuses Novo Nordisk’s once-weekly semaglutide




Novo Nordisk has received a refusal to file letter from the US Food and Drug Administration (FDA) for a label expansion application for semaglutide.

The application, filed on 20 January 2021, is seeking an expanded approval for once-weekly semaglutide 2.0mg for the treatment of type 2 diabetes.

In a statement, Novo said that the FDA has requested additional information, including data relating to a proposed new manufacturing site, in its letter.

The company added that it believes the already completed clinical trial programme will be ‘sufficient’ for approval of the label expansion application.

The FDA initially approved oral semaglutide under the brand name Rybelsus in September 2019, making it the first glucagon-like peptide (GLP-1) receptor protein treatment approved in the US that does not need to be injected.

Novo is expecting to resubmit the application for once-weekly semaglutide to the FDA in the second quarter of 2021.



Source link

Stay Connected

1,605FansLike
11,000FollowersFollow
342FollowersFollow
775FollowersFollow

Latest Articles

Covid’s second wave proves lethal for pregnant women

At SVP Hospital in Ahmedabad – one of the major Covid-19 hospitals of the city – 148 pregnant women with Covid-19 infection were admitted...

7 Tips to Keep Your Gut Healthy

This is common to say health (and illness) starts in your gut. If you have poor gut health, you’ll experience anything from wrinkled skin, to...

SII making first batch of Covovax: Poonawalla

The first batch of Covovax, a Covid-19 vaccine developed by Novavax Inc, is being manufactured at the Serum Institute of India's Pune facility, SII...

Sputnik V is safest among all Covid-19 vaccines, no deaths recorded: Buenos Aires study

A study by the Buenos Aires Ministry of Health to monitor the safety of the Sputnik V vaccine against Covid-19 confirmed on Thursday that...

Telangana caps Covid treatment charges in private hospitals

Hyderabad: The government of Telangana on Wednesday issued orders fixing treatment and investigation charges for Covid-19 in private hospitals.The state government, which had capped...