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Fri, Jul 11, 2014

FDA approves generic form of Cymbalta

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WASHINGTON – The U.S. Food and Drug Administration approved Thursday the first generic versions of Cymbalta, a prescription medicine used to treat depression and other conditions.

Officials said six companies have received FDA approval to market duloxetine, the generic form of Cymbalta, in various strengths.

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

As with other antidepressants, duloxetine will have a boxed warning describing the increased risk of suicidal thinking and behavior during initial treatment in children, adolescents, and young adults who are between 18 and 24 years old.

The warning also informs consumers that data do not show this increased risk in those older than 24 years, while patients 65 years old and older who take antidepressants have been found to have a decreased risk of suicidal thinking and behavior.

Depression and other serious psychiatric disorders themselves are the most important causes of suicide, and close monitoring of patients starting these medications is necessary, according to agency.

Officials said approved generic prescription drugs, including duloxetine, have the same high quality and strength as brand-name drugs and must pass the same quality standards as those of brand-name drugs.

For more information about duloxetine, visit www.fda.gov.


-- Marie Kemph, mkemph@murfreesboropost.com

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