Generic Cymbalta Approved

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.

Duloxetine is prescribed to treat symptoms of depression, which may include: depressed mood, loss of interest in usual activities, changes in weight or appetite, sleep problems, feelings of guilt or worthlessness, inability to concentrate or suicidal thoughts, the FDA said.

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 are equivalent in effect and strength to their brand-name counterparts, the FDA said.

More information

The FDA has more about this approval.