Teva Pharmaceutical Industries Ltd. Has won U.S. approval to sell the first generic version of Lexapro for depression and anxiety. Teva has been granted a 180-day exclusivity, so no other firm can market the generic medication in the United States in that timeframe, the Food and Drug Administration (FDA) said in a news release.
Generic drugs have the same high quality and strength as their brand-name predecessors, and must pass the same quality standards, the agency stressed. Brand-name Lexapro, produced by Forest Laboratories, was approved by the FDA in 2002.
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.
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.
Escitalopram, as with similar antidepressants, has a boxed label warning about increased risk of suicidal thinking, especially among children, teens and young adults. Other potential side effects include changes in sleep pattern, low sex drive, nausea and increased sweating, the FDA said.