DETROIT, Nov. 30 Caraco PharmaceuticalLaboratories, Ltd., (Amex: CPD) announced today that the US Food and DrugAdministration (FDA) has granted tentative approval for the Company'sAbbreviated New Drug Application (ANDA) for Escitalopram Oxalate Tablets(escitalopram), 5 mg, 10 mg, and 20 mg.
Escitalopram is indicated for the treatment of major depressive disorder.This tentative approval is for the generic bioequivalent product toLexapro(R), which is offered by Forest Laboratories, Inc. Lexapro(R) tabletshad U.S. sales of approximately $2.5 billion for the 12-month period ending onSeptember 30, 2007, according to IMS Data.
Daniel H. Movens, Caraco's Chief Executive Officer, said, "We areextremely pleased to receive this tentative approval. The ANDA was filed witha Paragraph IV certification that we do not infringe Forest's Lexapro(R)patents or that they are invalid. As previously disclosed, we are currentlyinvolved in litigation with Forest Laboratories that will determine whether wemay launch our generic product prior to the expiration of these patents.Though the outcome of this litigation is uncertain, we remain confident in ourposition and continue to expect a favorable conclusion."
Detroit-based Caraco Pharmaceutical Laboratories, Ltd., develops,manufactures, markets and distributes generic and private-labelpharmaceuticals to the nation's largest wholesalers, distributors, drugstorechains and managed care providers.
Safe Harbor: This news release contains forward-looking statements madepursuant to the safe-harbor provisions of the Private Securities LitigationReform Act of 1995. Such statements are based on management's currentexpectations and are subject to risks and uncertainties that could causeactual results to differ materially from those described in the forward-looking statements. These risks and uncertainties are contained in theCorporation's filings with the Securities and Exchange Commission and include,but are not limited to: information of a preliminary nature that may besubject to adjustment, potentially not obtaining or delay in obtaining FDAapproval for new products, governmental restrictions on the sale of certainproducts, development by competitors of new or superior products or cheaperproducts or new technology for the production of products, the entry into themarket of new competitors, market and customer acceptance and demand for newpharmaceutical products, availability of raw materials, timing and success ofproduct development and launches, dependence on few products generatingmajority of sales, product liability claims for which the Company may beinadequately insured, and other risks identified in this report and from timeto time in our periodic reports and registration statements. These forward-looking statements represent our judgment as of the date of this report. Wedisclaim, however, any intent or obligation to update our forward-lookingstatements.
SOURCE Caraco Pharmaceutical Laboratories, Ltd.