FDA Okays First Cymbalta Generics

Caroline Cassels

Disclosures

December 11, 2013

The US Food and Drug Administration (FDA) has approved the first generic versions of the antidepressant duloxetine, delayed-release capsules (Cymbalta, Eli Lilly and Company).

Six pharmaceutical companies including Aurobindo Pharma Ltd, Dr. Reddy's Laboratories Ltd, Lupin Ltd, Sun Pharma Global FZE, Teva Pharmaceuticals USA, and Torrent Pharmaceuticals Ltd have received FDA approval to market duloxetine in various strengths.

"Health care professionals and consumers can be assured that these FDA-approved generic drugs have met our rigorous standards," said Kathleen Uhl, MD, 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."

Duloxetine and other antidepressant drugs have a boxed warning describing the increased risk for suicidal ideation and behavior during initial treatment in children, adolescents, and young adults aged 18 to 24 years, but this risk is decreased in those aged over 24 years.

According to the FDA, approved generics have equivalent efficacy to brand-name drugs. Generic prescription drug manufacturing and packaging sites must pass the same quality standards as those of brand-name drugs, the agency notes.

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