www.fdanews.com/articles/114411-fda-updates-warning-for-two-classes-of-antidepressants
FDA Updates Warning for Two Classes of Antidepressants
February 6, 2009
The FDA is requiring manufacturers of two types of antidepressants, selective serotonin reuptake inhibitors and serotonin-norepinephrine reuptake inhibitors, to update their drug warnings with information on neuroleptic malignant syndrome. The agency sent letters to numerous drugmakers, requesting the labeling updates and invoking section 505(o)(4) of the Food, Drug and Cosmetic Act that gave it new powers to require safety-related labeling changes for drugs under the FDA Amendments Act.
Drug Industry Daily
Drug Industry Daily