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...
You've probably seen the television commercials or magazine ads for Cymbalta, and you might be wondering what makes it different from other antidepressants. Since I know that the writing in the medication insert is dense enough to make your eyes cross and your head nod, I've distilled some of the basic information about it here.
Cymbalta (duloxetine) is a serotonin-norepinephrine reuptake inhibitor (SNRI) prescribed for the treatment of depression, anxiety, stress urinary incontinence, nerve pain and fibromyalgia. Other antidepressants in the SNRI family that you may have heard of are Effexor and Serzone. SNRIs act on two neurotransmitters in the brain, namely serotonin and norepinephrine, to prevent their reabsorption after they act on receptors.
As with several other SNRIs, Cymbalta's most common side effects are nausea, dry mouth, drowsiness, headache, changes in appetite, vivid dreams, dizziness and sexual side effects. This is ...
You should knowAnswers to your question are meant to provide general health information but should not replace medical advice you receive from a doctor. No answers should be viewed as a diagnosis or recommended treatment for a condition. Content posted by community members does not necessarily reflect the views of Remedy Health Media, which also reserves the right to remove material deemed inappropriate.