FDA Cancels Advisory Panel On Lilly Drug Cymbalta
January 05 2010 - 10:15AM
Dow Jones News
The Food and Drug Administration has canceled an advisory panel
meeting involving Eli Lilly & Co.'s (LLY) antidepressant
Cymbalta.
The company is seeking wider approval of the product to treat
chronic pain. Along with depression, Cymbalta is also approved to
treat diabetic nerve pain and fibromyalgia, another pain disorder.
Cymbalta is one of Lilly's top-selling drugs, with $2.7 billion in
annual sales in 2008.
Cymbalta had been scheduled to be evaluated on Jan. 28 by the
FDA's anesthetic and life support drugs advisory committee. Outside
medical experts who serve on FDA panels typically are asked to make
recommendations about whether the agency should approve a
particular product. The FDA is not required to follow the advice of
its panels but usually does.
In a notice posted on the FDA's Web site Tuesday, the agency
said the meeting was cancelled "to allow time for the FDA to review
new information that is relevant to the benefit risk balance for
the proposed new indication."
The FDA said it would keep evaluating the application and might
bring the matter to a future advisory panel.
Lilly submitted its Cymbalta application to the agency in June
2009 after previously withdrawing the application in Nov. 2008. The
company resubmitted the application with additional information
from clinical trials involving chronic low back pain and
osteoarthritis pain.
-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294;
jennifer.corbett@dowjones.com
Eli Lilly (NYSE:LLY)
Historical Stock Chart
From Mar 2024 to Apr 2024
Eli Lilly (NYSE:LLY)
Historical Stock Chart
From Apr 2023 to Apr 2024
