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FDA Approves Generic Cymbalta (Duloxetine)

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FDA Approves Generic Cymbalta (Duloxetine)

Labeling states drug/other antidepressants could up risk of suicidal thoughts/action

THURSDAY, Dec. 12, 2013 (HealthDay News) -- The first generic versions of the antidepressant drug Cymbalta (duloxetine delayed-release capsules) have been approved by the U.S. Food and Drug Administration.

License to produce generic Cymbalta was granted to Aurobindo Pharma Ltd., Dr. Reddy's Laboratories Ltd., Lupin Ltd., Sun Pharma Global FZE, Teva Pharmaceuticals USA, and Torrent Pharmaceuticals Ltd., the agency said Wednesday in a news release.

Labeling on duloxetine and other antidepressants says these drugs could increase users' risks of suicidal thinking and behavior, particularly among children, teens, and young adults. Users should be monitored closely for these warning signs, the agency advised.

Common side effects of duloxetine include nausea, dry mouth, drowsiness, loss of appetite, increased sweating, and dizziness.

Generic drugs approved by the FDA are equivalent in quality and strength to their brand-name counterparts, the FDA said.

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