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.

Launched in 2004, Cymbalta has become Lilly's fastest-growing drug, with global sales of $1.3 billion in 2006. -SM