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Cymbalta gets FDA approval for long-term use

12/3/2007

INDIANAPOLIS Eli Lilly and Co.’s anti-depression drug, Cymbalta, has received government approval for long-term use, the company said Friday.

The Indianapolis-based drugmaker said that the Food and Drug Administration approved Cymbalta for “maintenance treatment” to help patients delay the time to a possible relapse into depression.

More than 9 million adults in the United States have been prescribed Cymbalta since its approval, Eli Lilly said in its report, while close to 19 million Americans suffer from major depressive disorder.

Lilly said patients normally take Cymbalta throughout the acute phase of depression, which ends when the person reaches full recovery, typically within three months. Lilly said. Continuing to take Cymbalta for several more months can help some patients avoid a relapse.

The maintenance treatment time period is determined by the physician, but often lasts for an additional four to nine months, Lilly said in its report.

Cymbalta is also approved for generalized anxiety disorder and diabetic peripheral neuropathic pain. The drug rang up sales of $1.3 billion last year, a 94 percent increase over 2005, making it Lilly’s fastest-growing drug, according to reports.

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