FDA issues warning letter over Cymbalta physician promo

Share this article:

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 on Tuesday, the agency said Lilly's promotion intended to promote its indication as a treatment for diabetic nerve pain was “false and misleading” and omitted some of the most serious and important risk information associated with its use.

The agency asked that Lilly stop using the material or similar promotions.

A Lilly 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 $1.3 billion in 2006.

Share this article:
You must be a registered member of MMM to post a comment.

Email Newsletters

More in News

Five things for Pharma Marketers to know: Friday, August 29

Five things for Pharma Marketers to know: Friday, ...

Takeda closes out a good-news, bad-news kind of week, AstraZeneca adds a new clinical trial for its experimental PD-1, and researchers link a funeral to the Ebola outbreak.

Amgen sends PCSK9 to FDA

Amgen sends PCSK9 to FDA

Evolocumab holds the FDA's first filed biologics license application for the class.

Consultants expect M&A tempo to continue

Consultants expect M&A tempo to continue

PwC anticipates that divestitures will fuel late-2014 deals, but notes that the noise around early deals and the financials don't fully match up.