Lilly granted Cymbalta marketing extension
  • Wed, 07/11/2012 - 11:32am

The U.S. Food and Drug Administration granted Eli Lilly & Co. six more months to market the Cymbalta. Thanks to the extension, generic versions of the drug will not be sold until December 2013.

The extension is a result of Cymbalta’s success at meeting the FDA’s requirements for pediatric exclusivity, a grant that gives manufacturers an extra six months to exclusively market their product or drug. Pediatric exclusivity shows that a product or drug is beneficial to the pediatric population; however, Cymbalta is currently approved for use in adults only because clinical trials revealed the drug increases suicidal thoughts in children, adolescents, and young adults.

According to the Wall Street Journal, the FDA granted the extension to Lilly because it studied the effects of Cymbalta in children. The company will not seek pediatric approval because the results of their study were inconclusive.

For more information about pediatric exclusivity, visit this link: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm077915.htm

The patent, which was scheduled to run out in June 2013, will now expire in December 2013.

Cymbalta is an antidepressant in a class of drugs called selective serotonin reuptake inhibitors (SSRIs). These drugs help balance the chemical in the brain said to cause depression. Cymbalta is currently approved for adults over age 18 to treat depression, generalized anxiety disorder, and painful conditions like stiff, tender and painful muscles, chronic muscle or bone pain, according to WebMD.

Depression is defined by the Mayo Clinic as “a medical illness that causes a persistent feeling of sadness and loss of interest.”

Common depressive symptoms include but are not limited to:

  • Sad or unhappy feelings
  • Irritability or frustration
  • Loss of interest or pleasure in normal activities
  • Reduced sex drive
  • Insomnia or excessive sleeping
  • Changes in appetite
  • Agitation or restlessness
  • Irritability or angry outbursts
  • Slowed thinking, speaking or body movements
  • Indecisiveness, distractibility and decreased concentration
  • Fatigue, tiredness and loss of energy
  • Feelings of worthlessness or guilt
  • Trouble thinking, concentrating, making decisions and poor memory
  • Suicidal thoughts or thoughts of death
  • Crying without reason
  • Unexplained pain and aches

If you believe you suffer from depression, it is best to seek help from your healthcare professional early to treat your condition right away.

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