Sanofi-Aventis’ New Ambien Wins FDA OK
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Sanofi-Aventis said U.S. regulators approved a long-acting version of sleep aid Ambien, which loses patent protection next year.
The Food and Drug Administration approved Ambien CR for use in helping people both fall and stay asleep, Paris-based Sanofi said.
The approval in both uses may help Sanofi protect Ambien sales from competition by Lunesta, introduced earlier this year by Sepracor Inc. Ambien loses patent protection in October 2006 and Sanofi hopes to switch patients to the new version, which is expected to go on sale by year-end.
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