December 25, 2013
Generic Cymbalta Begins to Come on Market With
FDA Approval

Washington, D.C.—Within hours after FDA approval of the first generic versions of Cymbalta (duloxetine delayed-release capsules), manufacturers began announcing that they were launching marketing of the depression drug in various strengths.

Receiving approval to market duloxetine were Aurobindo Pharma Ltd., Lupin Ltd., Dr. Reddy’s Laboratories Ltd., Sun Pharma Global FZE, Teva Pharmaceuticals USA, and Torrent Pharmaceuticals Ltd.

On December 11, when FDA’s action was announced, Citron Pharma LLC announced that its New Jersey-based business had launched Duloxetine Delayed-Release Capsules USP in 20-mg, 30-mg, and 60-mg strengths. Citron said it had received final approval from the FDA for the Abbreviated New Drug Application it had exclusively licensed for this product and would begin shipping immediately.

A day later, Lupin Pharmaceuticals, Inc. said it had launched its 20-mg, 30-mg, and 60-mg strength capsules.

The patent on Cymbalta, marketed by Eli Lilly & Co. Inc., expired earlier this month. The Lupin press release noted that Cymbalta Delayed-Release Capsules 20-mg, 30-mg, and 60-mg strengths had annual U.S sales of approximately $5.43 billion

Widespread availability of the generic is expected within the first two quarters of 2014.

“Health care professionals and consumers can be assured that these FDA-approved generic drugs have met our rigorous standards,” said Kathleen Uhl, MD, 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.”

A boxed warning on duloxetine and other antidepressant drugs cautions about the increased risk of suicidal thinking and behavior during initial treatment in children, adolescents, and young adults ages 18 to 24. The warning also says data do not show this increased risk in those older than 24 years and that patients ages 65 and older who take antidepressants have a decreased risk of suicidal thinking and behavior.

The warning adds that depression and other serious psychiatric disorders themselves are the most important causes of suicide and that close monitoring of patients starting these medications is necessary.

As with Cymbalta, duloxetine must be dispensed with a patient medication guide that describes important information about the drug’s uses and risks. Common adverse reactions reported by people taking Cymbalta include nausea, dry mouth, drowsiness, fatigue, decreased appetite, increased sweating, and dizziness.

The FDA pointed out that generic prescription drugs approved by the agency have the same high quality and strength as brand-name drugs, adding that manufacturing and packaging sites must pass the same quality standards as those of brand-name drugs.

U.S. Pharmacist Social Connect