WASHINGTON The FDA has granted tentative approval for Caraco’s abbreviated new drug application for escitalopram oxalate tablets (escitalopram), 5 mg, 10 mg and 20 mg.
Escitalopram is indicated for the treatment of major depressive disorder and is the generic bioequivalent of Forest Laboratories’ Lexapro.
Caraco and Forest Laboratories have been involved in a patent litigation over the generic Lexapro since July. Lexapro tablets had U.S. sales of approximately $2.5 billion for the 12-month period ending Sept. 30, Caraco said.
“We are extremely pleased to receive this tentative approval,” said Caraco’s chief executive officer, Daniel Movens. “The ANDA was filed with a Paragraph IV certification that we do not infringe Forest’s Lexapro patents or that they are invalid. As previously disclosed, we are currently involved in litigation with Forest Laboratories that will determine whether we may launch our generic product prior to the expiration of these patents. Though the outcome of this litigation is uncertain, we remain confident in our position and continue to expect a favorable conclusion.”