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US FDA objects to TV ad for Rozerem sleep drug

Thu Mar 8, 2007 1:26pm EST

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Regulatory News

WASHINGTON, March 8 (Reuters) - A Takeda Pharmaceutical Co. (4502.T) television commercial for insomnia drug Rozerem should have included information about its risks, U.S. regulators said in a letter released on Thursday.

The Food and Drug Administration said the 10-second ad "was not an appropriate reminder ad." Reminder ads, which typically only mention a drug's name, do not need to balance benefit and risk information.

((Reporting by Lisa Richwine, editing by J.S. Benkoe; Reuters Messaging: lisa.richwine.reuters.com@reuters.net; +1 202 310-5691)) Keywords: TAKEDA AD/

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