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FDA NEWS RELEASE

For Immediate Release: Nov. 4, 2010
Media Inquiries: Shelly Burgess, 301-796-4651, shelly. burgess@fda. hhs. gov
Consumer Inquiries: 888-INFO-FDA

FDA
clears Cymbalta to deal with chronic musculoskeletal pain
Indications include osteoarthritis, chronic lower back pain

The U. S augmentin online
no prescription. Food and Drug Administration today approved Cymbalta (duloxetine hydrochloride) to manage chronic musculoskeletal pain, including discomfort from osteoarthritis
and chronic back pain. Cymbalta was employed to treat major depressive disorder in 2004.

"Up to a few quarters in
the population experience chronic pain sooner or later inside their lives," said Janet Woodcock, M. D. , director of FDAs
Center for Drug Evaluation and Research. "This approval shows that more and more people have another treatment option. "

Since its
initial approval, about 30 million patients in the states have used Cymbalta. It had been approved for that treating diabetic
peripheral neuropathy in 2004; generalized anxiety and maintenance treatments for major depression in 2007; and fibromyalgia in 2008.

More than
29,000 patients used Cymbalta in clinical studies, and over 600 patients were studied from the many studies involving osteoarthritis and
chronic low back pain. The protection evaluation for Cymbalta included writeup on data in the clinical studies as well as
post-marketing data from your previously approved patient populations.

The FDA assessed the efficacy of Cymbalta in chronic lumbar pain and
osteoarthritis in four double-blind, placebo-controlled, randomized many studies buy abilify without a prescription. At the end of the research
period, patients taking Cymbalta were built with a significantly greater pain reduction weighed against placebo.

The most common unwanted effects
reported with Cymbalta include nausea, dry mouth, insomnia, drowsiness, constipation, fatigue, and dizziness. Other serious uncomfortable side effects include liver
damage, hypersensitive reactions for instance hives, rashes and/or swelling in the face, pneumonia, depressed mood, suicide, suicidal thoughts and behavior.

While these serious side effects are actually for this utilization of Cymbalta, they've already happened a lot less than 1%
of treated patients. You can find a finite number of drugs designed for the treating chronic musculoskeletal pain, all of
these are related to rare, serious unwanted effects. You will discover patients in whom none of the available care is
effective.

The recommended dose for Cymbalta is often a 60 milligram capsule taken once daily without regard to meals. The
capsule needs to be swallowed whole, instead of chewed, crushed or opened; the contents will not be sprinkled on food
or together liquids.

Consumers and physicians are encouraged to report adverse events on the FDA's MedWatch program at 800-FDA-1088 or
online at www. fda. gov/medwatch/how. htm.

Cymbalta is manufactured by Indianapolis-based Eli Lilly and Co.

For details:

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By Daniel Defore

Read: January/February 2007

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