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news.Takeda has removed a TV advert for its sleeping drug Rozerem after the FDA said it did not include information about its risks.
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US regulators also criticised Takeda for suggesting that the insomnia treatment was safe for use in children. The FDA said that the safety of effectiveness of the drug had not been established in pediatric patients.
The Food and Drug Administration said the advert was not an appropriate reminder ad. A reminder ad usually mentions the pharmaceutical brand name but not the indication or medical condition it treats.
The ad also did not contain any warnings against use with alcohol and other risks associated with the drug. Takeda has been asked to remove the advert by the agency.
Rozerem was launched in the US in September 2005, and the drug had $26 million in sales as of March 2006, according to Takeda’s annual report.