The Food and Drug Administration (FDA) announced today its approval of duloxetine, the generic version of the brand name antidepressant, Cymbalta. The agency says the move will make drug access easier and cheaper for countless victims of depression, a devastating chemical imbalance that Duloxetine saps a person of many emotional functions.
“Health care professionals and consumers can be assured that these FDA-approved generic drugs have met our rigorous standards,” Dr. Kathleen Uhl, acting director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research, said in a news release. “Generic drugs offer greater access to health care for many people.”
Oftentimes, the introduction of a generic drug into the market fosters competition between drug companies looking to obtain greater market share. This leads to a drop in price among both the generic drugs, and interestingly, the name brand drugs as well, as the FDA requires the generic drug to be “comparable to a brand/reference listed drug product in dosage form, strength, route of administration, quality and performance characteristics, and intended use.”
Duloxetine is a delayed-release tablet taken orally, absorbing in the body roughly two hours after ingestion. Due to the observed increase in suicidality during clinical trials of duloxetine, all drug manufacturers must include a black box warning stating the added risk for people under the age of 24. The FDA reports that data do not show people over 24 to have an increased risk, and people over 65 actually have a decreased risk.
As a psychiatric disorder, depression affects roughly one in 10 Americans, according to the Centers for Disease Control and Prevention (CDC). The U.S. is one of four countries, in fact, where more than a third of all citizens report having had at least one major depressive episode at some point in their lives. Depression is not always diagnosed as a disorder — at times it’s marked simply by low mood as a result from life events — however, in the majority of cases, depression manifests as the more severe condition, known as Major Depressive Disorder. Sufferers report a variety of symptoms, including intense disinterest, insomnia, hypersomnia, decreased appetite, feelings of worthlessness, guilt, and sometimes thoughts of suicide.
Drugs targeting depression, including duloxetine, focus on the brain’s monoamine chemicals, such as serotonin, norepinephrine, and dopamine, which together help to create pleasurable feelings and sensations of happiness. An imbalance among these neurotransmitters is believed to emerge as what’s known more commonly as a mood disorder.
So far, various strengths of duloxetine have been market-approved for Aurobindo Pharma Ltd., Dr. Reddy’s Laboratories Ltd., Lupin Ltd., Sun Pharma Global FZE, Teva Pharmaceuticals USA, and Torrent Pharmaceuticals Ltd. The FDA states that “information about the availability of generic duloxetine can be obtained from the manufacturers.”