FDA approves the first generic versions of depression drug Cymbalta

December 12, 2013

FDA announced that it had given approval to several pharmaceutical companies to market duloxetine delayed-release capsules (Cymbalta, Eli Lilly), for the treatment of depression and other conditions. in various strengths. Companies named were Aurobindo Pharma Ltd., Dr. Reddy’s Laboratories Ltd., Lupin Ltd., Sun Pharma Global FZE, Teva Pharmaceuticals USA, and Torrent Pharmaceuticals Ltd.

FDA announced that it had given approval to several pharmaceutical companies to market duloxetine delayed-release capsules (Cymbalta, Eli Lilly), for the treatment of depression and other conditions. in various strengths. Companies named were Aurobindo Pharma Ltd., Dr. Reddy’s Laboratories Ltd., Lupin Ltd., Sun Pharma Global FZE, Teva Pharmaceuticals USA, and Torrent Pharmaceuticals Ltd.

“The approval of the generic version of Cymbalta offers the opportunity to access another affordable treatment option that might not have been a choice for some patients, due to their inability to pay for the brand-name version,” said Formulary advisor Abimbola Farinde, PharmD, MS, who serves on the faculty at Columbia Southern University, Orange Beach, Ala.

People who struggle to accomplish daily tasks and activities that were previously normal parts of their routines, such as eating and sleeping, fulfillment of professional duties, and pursuit of formerly enjoyable pastimes, may face a diagnosis of depression, a condition that can be a recurrent or chronic challenge throughout life.

Patients, their families, and healthcare providers should watch for signs and symptoms that include depressed mood, loss of interest in usual activities, notable change in weight or appetite, insomnia or excessive sleeping, restlessness and/or pacing, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and self-destructive thoughts or suicide attempts.

Children, adolescents, and young adults (aged 18 to 24 years) are at greater risk of suicidal thinking and behavior during initial treatment, and duloxetine and other antidepressants include a boxed warning to that effect.

The warning notes that depression and other serious psychiatric disorders are the most important causes of suicide and patients beginning treatment with these medications should be closely monitored. A patient medication guide is dispensed with this product.

Some common adverse effects connected with use of duloxetine include nausea, dry mouth, drowsiness, fatigue, decreased appetite, increased sweating, and dizziness.

Queries about the availability of generic duloxetine should be addressed to the manufacturers.