FDA OKs Generic Depression Drug

Generic Version of Lexapro Gets Green Light

By Miranda Hitti
WebMD Medical News

Reviewed By Louise Chang, MD
on Tuesday, May 23, 2006

May 23, 2006 -- The FDA has approved a generic version of the antidepressant Lexapro (escitalopram oxalate).

The generic tablets will be available in three doses: 5 milligrams, 10 milligrams, and 20 milligrams. The drug is a selective serotonin reuptake inhibitor (SSRI), a family of drugs that also includes Prozac, Celexa, Zoloft, and Paxil .

Brand-name Lexapro -- made by Forest Laboratories, Inc. -- is the No. 2 antidepressant in filled prescriptions and the No. 3 antidepressant for total U.S. sales, as of February 2006, according to IMS Health Incorporated, a pharmaceutical market intelligence company.

The generic version of the drug will be made by Ivax Corp., a Miami-based subsidiary of Israel's Teva Pharmaceutical Industries.

A Teva news release states that “Teva is currently in patent litigation concerning this product” in a U.S. district court.

The FDA has not released detailed information on generic escitalopram oxalate's approval history and labeling.

SOURCES: FDA: “Drug Details: Escitalopram Oxalate (Generic Drug).” WebMD Medical Reference from “Making the Antidepressant Decision”: “Selective Serotonin Reuptake Inhibitors.” IMS Health Incorporated: “Commonly Requested Therapeutic Class and Product Information (updated February 2006.” News release, Teva. Associated Press.

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