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First generic Lexapro gets FDA approval

March 15, 2012
by Nick Zubko, Associate Editor
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Since it was approved by the FDA in 2002, Lexapro (escitalopram) has become a widely prescribed medication to treat both depression and generalized anxiety disorder in adults. Yesterday, the agency approved the first generic version of the drug.

Teva Pharmaceutical, which acquired IVAX in 2005, will now market generic escitalopram tablets in strengths of 5, 10, and 20 mg. The company was granted a “period of exclusivity,” which means the FDA can’t approve another version of the drug for 180 days.

According to Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, the medication is “widely used by people who must manage their condition over time.

“It is important to have affordable treatment options,” Woodcock said in a release from the FDA.

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Nick Zubko

Associate Editor

Nick Zubko

@BH_Zubko

www.behavioral.net

Nick Zubko is associate editor of Behavioral Healthcare.