US FDA objects to TV ad for Rozerem sleep drug
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/
(C) Reuters 2007. All rights reserved. Republication or redistribution ofReuters content, including by caching, framing or similar means, is expresslyprohibited without the prior written consent of Reuters. Reuters and the Reuterssphere logo are registered trademarks and trademarks of the Reuters group ofcompanies around the world.nWBT006655
© Thomson Reuters 2009 All rights reserved

