The U.S. Food and Drug Administration (FDA) earlier today approved the first generic versions of Cymbalta (duloxetine delayed-release capsules). Cymbalta is an antidepressant that is primarily used to treat depression, but is also prescribed for other conditions.
Cymbalta has been one of the most commonly prescribed antidepressants in the past five years. Generic versions of the drug will be available for much lower cost than the name-brand version.
Duloxetine will be available from multiple companies who have been licensed to provide the generic version of the drug. Generic versions of approved medications have the same active ingredients and must meet other stringent FDA guidelines before being approved.
Common adverse reactions reported by people taking Cymbalta include nausea, dry mouth, drowsiness, fatigue, decreased appetite, increased sweating and dizziness.
According to the FDA, duloxetine carries a boxed warning describing an increased risk of suicidal thinking and behavior during initial treatment in children, adolescents, and young adults ages 18 to 24. The warning also says data do not show this increased risk in those older than 24 years and that patients ages 65 and older who take antidepressants have a decreased risk of suicidal thinking and behavior.
Generic prescription drugs approved by the FDA have the same high quality and strength as brand-name drugs. Generic prescription drug manufacturing and packaging sites must pass the same quality standards as those of brand-name drugs.
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 (hypersomnia), restlessness/pacing (psychomotor agitation), increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and suicide attempts or thoughts of suicide.
The generic versions of Cymbalta should be available sometime in the first or second quarter of 2014.