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First Generic Lexapro Approved

First Generic Lexapro Approved

03/14/12

WEDNESDAY, March 14 (HealthDay News) -- The Israeli drug maker Teva Pharmaceuticals has gained the first U.S. approval to market generic Lexapro (escitalopram) to treat depression and general anxiety disorder, the U.S. Food and Drug Administration said Wednesday.

Teva was granted 180-day exclusivity, so no other firm can market the generic medication in the United States in that timeframe, the agency said in a news release.

Symptoms of major depression include depressed mood, loss of interest in once pleasurable activities, weight or appetite change, sleep changes, feelings of guilt or worthlessness or thoughts of suicide.

Symptoms of general anxiety disorder include exaggerated worry, always anticipating the worst, inability to relax and difficulty concentrating.

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.

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.

More information

To learn more about this drug, visit Medline Plus.

Copyright © 2012 HealthDay. All rights reserved.

Please be aware that this information is provided to supplement the care provided by your physician. It is neither intended nor implied to be a substitute for professional medical advice. CALL YOUR HEALTHCARE PROVIDER IMMEDIATELY IF YOU THINK YOU MAY HAVE A MEDICAL EMERGENCY. Always seek the advice of your physician or other qualified health provider prior to starting any new treatment or with any questions you may have regarding a medical condition.

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