Dr. Kathleen Uhl, acting director of the Office of Generic Drugs in the FDA's Center for Drug Evaluation and Research, said Aurobindo Pharma Ltd., Dr. Reddy's Laboratories Ltd., Lupin Ltd., Sun Pharma Global FZE, Teva Pharmaceuticals USA and Torrent Pharmaceuticals Ltd. received FDA approval to market duloxetine -- Cymbalta -- in various strengths.
"Healthcare professionals and consumers can be assured that these FDA-approved generic drugs have met our rigorous standards," Uhl said in a statement. "Generic drugs offer greater access to healthcare for many people."
Depression is characterized by symptoms that interfere with a person's ability to work, sleep, study, eat and enjoy once-pleasurable activities. Episodes of depression often recur throughout a person's lifetime. Signs and symptoms of depression include: depressed mood, loss of interest in usual activities, significant change in weight or appetite, insomnia or excessive sleeping, restlessness/pacing, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, suicide attempts or thoughts of suicide.
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 ages 18-24. The warning also says data do not show this increased risk in those older than age 24, while patients age 65 and older who take antidepressants have a decreased risk of suicidal thinking and behavior.
The warning says 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, Uhl said. Duloxetine must be dispensed with a patient medication guide that describes important information about the drug's uses and risks.