Eli Lilly and Co.'s antidepressant Cymbalta was approved for long-term use to help patients avoid a relapse into depression.
Cymbalta, one of Lilly's biggest-selling drugs, was first approved by the Food and Drug Administration in 2004 to treat serious depression. The new FDA approval supports its use for "maintenance treatment" in adults.
"This approval from the FDA is important because data from our Cymbalta clinical trial demonstrate that continuing to treat the patient delays the time to possible relapse," said Dr. Doug Williamson, Lilly's associate medical director for Cymbalta.
About 9 million people in the U.S. have taken Cymbalta, which is also approved to treat diabetic nerve pain and general anxiety disorder.
Lilly reported that Cymbalta had sales of $1.3 billion (880 million EUR) last year, making it the company's fastest-growing drug.
The FDA last month asked Lilly to stop a Cymbalta mailing that promoted the drug's use for diabetic nerve pain, saying it made misleading claims and did not give precautions about liver toxicity, among other concerns.