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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

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A regular roundup of commercial stories appearing in Scrip’s sister publication PharmAsia News, whose multilingual team of regional experts provides authoritative business intelligence focused on the Asian marketplace. Full stories can be accessed by clicking on the story title (subscription required).

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