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FDA questions new info about Eli Lilly’s Cymbalta, cancels review meeting

2010-01-06 01:08:17 (GMT) (Caymanmama.com - Business Health News News)

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Eli Lilly

Detroit, Michigan (CaymanMama.com) — Cymbalta, a drug by Indianapolis based Eli Lilly & Co., is an antidepressant typically used to treat depression, generalized anxiety disorder, diabetic nerve pain and fibromyalgia.

On Tuesday, the Food and Drug Administration canceled a meeting to review the antidepressant for a new treatment use for chronic pain, stating the Jan. 28 meeting would be called off “to allow time for the FDA to review new information,” about the proposed use, according to an official statement.

According to the Associated Press, “Lilly withdrew an application in November 2008 after FDA reviewers questioned the methodology and dosing in some of the company’s trials.”

Lilly then resubmitted a new application with an enclosed study of Cymbalta’s possible use for chronic pain caused by osteoarthritis, along with new information from a study of lower back pain.

Cymbalta is the drug-makers second-best selling product, following the anti-psychotic Zyprexa, having brought in $2.24 billion in sales through the the majority of 2009.

Eli Lilly & Co. is working overtime to protect the impending expiration of Cymbalta’s patent which ends in 2013.



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