Lilly pulls FDA application for Cymbalta for pain

CHICAGO (Reuters) - Eli Lilly and Co (LLY.N) said on Friday it withdrew an application to market its anti-depressant Cymbalta for the management of chronic pain because U.S. health regulators raised questions about the drug's effectiveness and dosing.

Lilly said it made its decision to pull the supplemental New Drug Application for Cymbalta, or duloxetine HCl, after U.S. Food and Drug Administration reviewers questioned the design of supporting Lilly studies and statistical methodology.

The maker of schizophrenia drug Zyprexa, osteoporosis treatment Evista, and cancer drug Alimta, said it plans to resubmit the application to the FDA in the first half of 2009, after adding data from a recently completed study in chronic osteoarthritis pain of the knee.

The decision does not affect the drug's existing FDA-approved indications for major depressive disorder, generalized anxiety disorder, management of diabetic peripheral neuropathic pain and management of fibromyalgia, Lilly said.

Lilly posted third-quarter sales of $716.4 million for Cymbalta, its second-largest revenue-generating drug after Zyprexa, up 40 percent from a year earlier. Cymbalta sales in the first three quarters of the year were $1.97 billion, up 34 percent from the 2007 period.

Shares of Lilly were 56 cents higher at $33.43 in morning New York Stock Exchange trade. The shares have traded in a range between $28.64 and $57.52 during the past 52 weeks.

(Reporting by Debra Sherman, editing by Gerald E. McCormick)