The U.S. Food and Drug Administration on Wednesday approved generic versions of Eli Lilly and Co's antidepressant Cymbalta, the U.S. drugmaker's biggest-selling product.
The drug, which has annual sales of about $5 billion, was expected to lose patent protection this month.
The FDA said it approved cheaper versions of the drug, known chemically as duloxetine, in a variety of strengths for sale by several generic drugmakers, including Teva Pharmaceutical Industries Ltd, Aurobindo Pharma Ltd, Dr. Reddy's Laboratories Ltd, Lupin Ltd, Sun Pharmaceutical Industries and Torrent Pharmaceuticals Ltd.
"Health-care professionals and consumers can be assured that these FDA-approved generic drugs have met our rigorous standards," Kathleen Uhl, acting director of the FDA's Office of Generic Drugs, said in a statement.
Once numerous generic versions of a medicine become available, the branded drug often loses more than 80 percent of its sales in the first year.
(Reporting by Bill Berkrot; Editing by Leslie Adler)