From Our 2006 Archives

FDA OKs Generic Depression Drug

Generic Version of Lexapro Gets Green Light

ByMirandaHitti
WebMD Medical News

Reviewed ByLouiseChang,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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