Generic Versions of Cymbalta Approved by the FDA

    December 12, 2013

The U.S. Food and Drug Administration (FDA) this week approved the first generic versions of the antidepressant duloxetine, commonly marketed as Cymbalta. The drug is a delayed-release medication used to treat depression and some other specific conditions.

The new generic versions of Cymbalta will function the same as the branded version of the drug, and at the same strength. This also means, however, that the generic version carries the same side effects of Cymbalta, including nausea, dry mouth, drowsiness, fatigue, decreased appetite, excessive sweating, and dizziness. The drugs also carry the increased risk of suicidal thinking in those younger than 24 years old – a side effect seen in a variety of antidepressant drugs.

The approval of the generic version of Cymbalta will bring the drug to market in the U.S. at a much lower price, allowing the drug to be used by a broader segment of Americans who may not be able to afford brand name drugs.

The FDA emphasized that generic versions of drugs are just as potent as their branded counterparts. The generics go through the same approval procedures as branded drugs and generic drug manufacturers and packagers must meet the same standards as those that manufacture and pack brand names. The generics must also come with medication guides.

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