FDA Denies Novo Nordisk Petition on Liraglutide Generics
By Zachary Brennan -
Published 08 January 2018
The US Food and Drug Administration (FDA) on Friday denied Novo Nordisk’s citizen petition that aimed to block generic versions of its blockbuster Victoza (liraglutide) and two other products containing liraglutide.
Categories: News, US, FDA, Drugs, Regulatory intelligence, Regulatory strategy, Submission and registration
Tags: liraglutide, citizen petition, Victoza generic
Novo Nordisk Pays $58M to Settle REMS Allegations
By Michael Mezher -
Published 06 September 2017
Danish drugmaker Novo Nordisk on Tuesday agreed to pay $58 million to settle allegations that the company failed to follow the risk evaluation and mitigation strategy (REMS) for its blockbuster diabetes drug Victoza (liraglutide).
Categories: News, US, DOJ, FDA, Advertising and Promotion, Communication, Drugs
Tags: Novo Nordisk, Victoza, REMS
Public Citizen Again Calls for Ban on Diabetes Drug Victoza
By Alexander Gaffney, RAC -
Published 06 June 2014
A prominent consumer watchdog group is calling on the US Food and Drug Administration (FDA) to withdraw its approval of the diabetes drug Victoza (liraglutide), which it says is linked to acute pancreatitis and several deaths.
Categories: News, US, CDER, Drugs, Postmarket surveillance, Product withdrawl and retirement
Tags: Novo Nordisk, Victoza, GLP-1, Public Citizen, Petition, Safety
Public Citizen to FDA: Diabetes Drug Unsafe, Should Be Pulled
By Alexander Gaffney -
Published 20 April 2012
Tags: Rosebraugh, Liraglutide, Victoza, Diabetes, Novo Nordisk, Wolfe, Public Citizen, Latest News, risks