shares slipped after the company said the Food & Drug Administration has pushed back the action date to approve Cymbalta, a potentially lucrative antidepressant, by as many as three months.
The delay comes in the wake of Lilly's submission of additional analysis of already-submitted data, per a request for more information from the FDA. The company said that approval could come in late September, but added that it believes the FDA will complete its final review of the drug before then.
The company reiterated its earlier guidance about the launch of Cymbalta, and expects to win approval and launch the drug this summer. Lilly is thought to have one of the best late-stage drug pipelines in the industry, and its shares have outperformed most rivals this year. Shares fell 59 cents, or 0.8%, to $72.14.
"We are eager to bring Cymbalta to market because it has the potential to help millions of people with depression," said John Lechleiter, executive vice president of pharmaceutical products. "We remain confident about the data we have submitted."