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FDA issues warning letter over mailer
THE FDA HAS issued Eli Lilly a warning letter over effectiveness claims the company made in a 2005 promotional mailer to physicians for its blockbuster antidepressant/nerve pain treatment Cymbalta.
In a letter posted to the FDA's Web site, the agency said Lilly's promotion intended to promote
The agency asked that Lilly stop using the material or any similar promos. A spokesman told The Indianapolis Star that the company is working with the FDA "to gain a greater understanding of their concerns." The spokesman said Lilly will take action once it has "more clarity" on the agency's comments.
The FDA asserts a 2005 mailer omitted serious risk info
Launched in 2004, Cymbalta has become Lilly's fastest-growing drug, with global sales of $1.3 billion in 2006. -SM
In addition, make sure to read these articles:
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- FDA to Lilly: Can Cymbalta journal ads
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