Last week the U.S. Food and Drug Administration approved the first generic versions of Cymbalta (duloxetine delayed-release capsules), a prescription medicine used to treat fibromyalgia, chronic musculoskeletal pain, diabetic neuropathy, depression and generalized anxiety disorder.
Aurobindo Pharma Ltd., Dr. Reddy’s Laboratories Ltd., Lupin Ltd., Sun Pharma Global FZE, Teva Pharmaceuticals USA, and Torrent Pharmaceuticals Ltd. Have all received FDA approval to market duloxetine in various strengths.
“Health care professionals and consumers can be assured that these FDA-approved generic drugs have met our rigorous standards,” said Kathleen Uhl, M.D., acting director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research. “Generic drugs offer greater access to health care for many people.”
Are Generic Drugs Really the Same?
In the news release announcing the approval of generic versions of Cymb...
It has long been thought that Cymbalta (generic name duloxetine) would be the second medication to receive FDA approval for the treatment of fibromyalgia . However, the disappointing results of the third phase III efficacy study could stall Lilly’s quest for approval. The 27-week phase III clinical trial randomized 330 fibromyalgia patients to either a 60 mg or 120 mg per day dose or to a placebo. Patients were allowed to switch between the 60 and 120 mg dosages during the study according to efficacy and tolerability. Study Results Cymbalta failed to achieve a statistically significant difference over the placebo in the primary outcome measures. The mean reduction in pain severity (measured by the Brief Pain Inventory) was 1.62 for Cymbalta and 1.12 for the placebo. The patients’ impressions of improvement scores averaged 3.42 for Cymbalta and 3.73 for the placebo. Cymbalta also showed no significant improvement in physical function. This study stands in stark contr...
Generic name: Duloxetine
Cymbalta is an antidepressant medication. It has been approved for use in treating symptoms of depression and generalized anxiety disorder (GAD). It is also used to treat fibromyalgia and diabetic neuropathy. Cymbalta is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI). Serotonin is a neurotransmitter in the brain and depression has been linked to the inability to create enough serotonin. Norepinephrine is another neurotransmitter linked to depression. Cymbalta targets both serotonin and norepinephrine, unlike SSRIs, which only target serotonin. Both of these neurotransmitters can impact mood. The medication works to block the neurotransmitters from reentering the nerves, allowing more of the neurotransmitters to remain active.
Clinical trials have shown Cymbalta to improve mood, increase appetite and allow for better sleep. It can also increase energy and decrease nervousness.
Generally, this medication is started...
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