Rozerem DTC Ad Suggests Insomnia Drug Is Indicated In Children - FDA
This article was originally published in PharmAsia News
Executive Summary
Takeda's direct-to-consumer TV ad for the insomnia drug Rozerem (ramelteon) fails to disclose the drug's indication, does not include information related to side effects and suggests through "back to school"-themed images and statements that the drug is indicated in children, FDA says in a warning letter issued to the company March 5 and posted online March 8