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Levothyroxine false claims lawsuit

Executive Summary

Watson is enjoined from making claims that Abbott's Synthroid is not safe and effective due to FDA's denial of its citizen petition, under a preliminary injunction granted by Chicago federal court Judge David Coar July 19. Watson is considering appealing the order. Abbott filed suit against Watson in June over Watson's promotions for its FDA-approved levothyroxine product Unithroid. Watson's claims "that Synthroid will be taken off the market come August 2001" were not found to be misleading, given FDA's "ambiguous" pronouncements about the fate of unapproved products, the decision says. FDA clarified its regulatory plans for unapproved levothyroxine products in a July 12 guidance (1"The Pink Sheet" July 16, p. 16)

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