FDAnews Drug Daily Bulletin

FDA Approves Generic Cymbalta

Dec. 13, 2013

The FDA Dec. 11 approved the first generic versions of Eli Lilly’s blockbuster antidepressant Cymbalta (duloxetine). The drug’s compound patent, as extended by pediatric exclusivity, expires this month.

Generic drugmakers Aurobindo, Dr. Reddy’s Laboratories, Lupin, Sun Pharma, Teva and Torrent have all received approval to market duloxetine in various strengths, the agency said.

The drug raked in just under $5 billion in global sales last year, according to Lilly.

Cymbalta, a selective serotonin/norepinephrine reuptake inhibitor, was first approved by the FDA to treat major depressive disorder in 2004. The drug has since been approved to treat four additional indications: generalized anxiety disorder, depression, fibromyalgia and as a chronic pain reliever, but only for patients with back pain. — Melissa Winn

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