UPDATE 1-US FDA cancels panel review of Lilly antidepressant
* Meeting was set for Jan. 28
* FDA says needs time to review new information
* Lilly shares end down 1.8 pct (Adds Eli Lilly comment)
WASHINGTON, Jan 5 (Reuters) - U.S. health officials have canceled an advisory panel review of Eli Lilly and Co's (LLY.N) proposed new use for blockbuster antidepressant Cymbalta, the Food and Drug Administration said on Tuesday.
The Jan. 28 meeting had been set to consider data from Lilly's application to promote Cymbalta for treatment of chronic pain.
The meeting was canceled "to allow time for the FDA to review new information that is relevant to the benefit risk balance for the proposed new indication," an FDA notice said.
"The agency intends to continue evaluating the application and, as needed, will announce future meeting dates," the notice said.
Eli Lilly said in an emailed statement that it has submitted one new efficacy/safety study with the routine 120-day update, which did not show any new safety signals.
"We also continue to respond to questions from FDA staffers ... as well as continue our routine safety monitoring that isn't specific to the chronic pain application," the company said.
The FDA often seeks advice from panels of outside experts before deciding whether to approve a drug application.
Cymbalta is one of Lilly's best-selling drugs with sales of nearly $2.7 billion in 2008. Known generically as duloxetine, the drug is already approved for treating depression, anxiety, diabetic nerve pain and fibromyalgia.
Doctors are free to prescribe it for other conditions, but Lilly needs FDA clearance to promote the drug for additional uses.
The company sought FDA approval for chronic pain in the second quarter of 2008 but withdrew the bid in November of that year. Lilly resubmitted its application in June 2009.
Lilly shares fell 1.8 percent to $35.19 on the New York Stock Exchange.