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Cymbalta FDA Approval History

FDA Approved: Yes (First approved August 3, 2004)
Brand name: Cymbalta
Generic name: duloxetine
Dosage form: Delayed-Release Capsules
Company: Eli Lilly and Company
Treatment for: Neuropathic Pain, Pain, Osteoarthritis, Generalized Anxiety Disorder, Depression, Fibromyalgia, Diabetic Kidney Disease

Cymbalta is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) indicated for the treatment of major depressive disorder, neuropathic pain associated with diabetic peripheral neuropathy, generalized anxiety disorder, fibromyalgia and chronic musculoskeletal pain.

Development Timeline for Cymbalta

Nov  5, 2010ApprovalFDA Clears Cymbalta to Treat Chronic Musculoskeletal Pain
Nov 30, 2009ApprovalFDA Approves Cymbalta for Maintenance Treatment of Generalized Anxiety Disorder
Jun 16, 2008ApprovalFDA Approves Cymbalta for the Management of Fibromyalgia
Nov 30, 2007ApprovalFDA Approves Cymbalta for Maintenance Treatment of Major Depressive Disorder
Feb 26, 2007ApprovalFDA Approves Cymbalta for Treatment of Generalized Anxiety Disorder
Sep  7, 2004ApprovalFDA Approves Cymbalta for Neuropathic Pain Associated With Diabetes
Aug  4, 2004ApprovalFDA Approves Cymbalta for the Treatment of Depression
Jun 24, 2004FDA Extends Action Date for Cymbalta for Continued Analysis of Already-Submitted Data

Further information

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