FDA Tentatively Approves Generic Lexapro

The FDA has granted tentative approval for Caraco’s abbreviated new drug application for Escitalopram Oxalate Tablets (escitalopram), 5, 10 and 20 mg.

Escitalopram is indicated for the treatment of major depressive disorder and is the generic bioequivalent of Forest Laboratories’ Lexapro.

Lexapro tablets had U.S. sales of approximately $2.5 billion for the 12-month period ending Sept. 30, Caraco said.