- Clinical Trials
- Research News
- Industry Trends
- Agency Actions
- Drug Safety Issues
- Approvals, Launches, & New Indications
- Health Care Reform
FDA Approves First Generic Versions of Antidepressant Drug Cymbalta (Duloxetine)
Boxed warnings highlight suicidal thinking in young people (December 11)
The FDA has approved the first generic versions of Cymbalta (duloxetine delayed-release capsules), a prescription medication used to treat depression and other conditions.
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.
Duloxetine and other antidepressant drugs have a boxed warning describing the increased risk of suicidal thinking and behavior during initial treatment in children, adolescents, and young adults 18 to 24 years of age. The warning also states that data do not show this increased risk in patients older than 24 years and that patients aged 65 years and older who take antidepressants have a decreased risk of suicidal thinking and behavior.
The warning also says that depression and other serious psychiatric disorders themselves are the most important causes of suicide and that close monitoring of patients starting these medications is necessary. Duloxetine must be dispensed with a patient medication guide that describes important information about the drug’s uses and risks.
Common adverse reactions reported by people taking duloxetine include nausea, dry mouth, drowsiness, fatigue, decreased appetite, increased sweating, and dizziness.
Source: FDA; December 11, 2013.