Teva Pharmaceutical Industries Ltd. won U.S. approval to sell the first generic version of Lexapro for depression and anxiety.
Teva, the world’s largest generic drugmaker, will have 180 days to exclusively sell the copy of the medicine, the Food and Drug Administration said today in a statement. Lexapro is Forest Laboratories Inc.’s top-seller, with $2.3 billion in sales for the fiscal year ended in March 2011.
“This medication is widely used by people who must manage their condition over time, so it is important to have affordable treatment options,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research.
Teva’s American depositary receipts fell 1.4 percent to $43.80 at the close of New York trading. Each receipt is equal to one ordinary share of the Petach Tikva, Israel-based company. New York-based Forest declined less than 1 percent to $33.69.
Both psychiatric conditions can be disabling and interfere with daily activities, Woodcock said. Major depression symptoms include loss of interest in usual activities, significant weight change, insomnia or excessive sleeping and suicidal thoughts. People with anxiety disorder worry excessively and have difficulty concentrating, according to the FDA.
The most common side effects with the drug were sleeplessness, ejaculation disorder, nausea, increase in sweating, fatigue, drowsiness and low sex drive.