FDA Approves First Generic Versions of Cymbalta

Patient Expert

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 Cymbalta, the FDA stated, "Generic prescription drugs approved by the FDA have the same high quality and strength as brand-name drugs.  Generic prescription drug manufacturing and packaging sites must pass the same quality standards as those of brand-name drugs."

Technically, those statements are true. Generic drugs are required to be bioequivalent to the brand name drug, meaning that two drugs given to the same patient in the same dosage regimen will result in equivalent concentrations of the drug in plasma and tissues.

However, the bioavailability of the generic drug the rate at which a drug is absorbed or becomes available to the body at its site of action can vary from the brand name by as much as plus or minus 20%. Therefore, although the strength of the generic may be the same as the brand name drug, how it works in the body of any given patient may vary.

To learn more about these differences, read "Brand Name vs. Generic Drugs: Are They Really the Same?

In most cases, generic drugs work as well as their brand name counterparts, with the added benefit of being significantly less expensive. But if you are switched from Cymbalta to one of the new generic versions and don't feel it is as effective for you, there are two options:

  • Ask your pharmacist if you can try another generic version from a different manufacturer.

  • Talk with your doctor and request that your prescription specify no generic substitutions.

Source: "FDA approves first generic versions of antidepressant drug Cymbalta" FDA News Release, December 11, 2013.