Novo Nordisk announced that the U.S. Food and Drug Administration (FDA) has informed the company that an FDA Advisory Committee meeting is tentatively scheduled to be held on Sept. 11, to discuss the New Drug Application (NDA) for liraglutide 3 mg for the treatment of obesity. The NDA was submitted to the FDA on Dec. 20, 2013.
FDA Advisory Committees are panels of independent experts who advise the FDA on specific questions raised by the FDA as they consider regulatory decisions. The FDA is not bound by the Committee’s recommendation, but it takes its advice into consideration when reviewing NDAs. According to the FDA Amendment Act of 2007 (FDAAA), the FDA should refer new drugs to an Advisory Committee meeting, or alternatively justify why an Advisory Committee meeting was not requested.
Date: May 20, 2014
Source: Novo Nordisk
Filed Under: Drug Discovery