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Generic Cymbalta approved by FDA

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The U.S. Food and Drug Administration today approved the first generic versions of Cymbalta (duloxetine delayed-release capsules), a prescription medicine used to treat depression and other conditions such as anxiety disorder, diabetic nerve pain, fibromyalgia and other chronic pains.

It is now estimated that 19 million Americans are now living with some form of major depression, interfering with their ability to live satisfying and productive lives, including the ability to work, sleep, eat, study and socialize with others, as well as a lack of interest in other pleasurable pursuits. Signs of depression are often evident in significant change in weight or appetite, increased fatigue, inability to sleep or sleeping too much, agitated movements (pacing/restlessness), increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and suicidal thoughts and attempts.

As with all antidepressant drugs, however, duloxetine can cause increased risk of suicidal thinking and behavior during initial treatment in children, adolescents, and young adults ages 18 to 24, as well as those 65 or older. Warnings on the box, however. do not show this increased risk in those 25-64.

Common side effects reported by people taking Cymbalta include nausea, dry mouth, drowsiness, fatigue, decreased appetite, increased sweating, and dizziness.

“Health care professionals and consumers can be assured that these FDA-approved generic drugs have met our rigorous standards,” said Kathleen Uhl, M.D., acting director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research. “Generic drugs offer greater access to health care for many people.”

For more information speak with your doctor or call the FDA consumer line at 888-INFO-FDA.



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