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Actavis (ACT) Sues FDA Regarding Delay Of Generic Celebrex® Approval


4/29/2014 10:08:28 AM

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DUBLIN
, April 28, 2014 /PRNewswire/ -- Actavis plc (NYSE: ACT) today announced that its subsidiary, Watson Laboratories, Inc., has filed suit against the U.S. Food and Drug Administration (FDA) challenging the Agency's decision regarding its entitlement to shared 180-day marketing exclusivity for its generic version of Celebrex® (celecoxib) 50 mg, 100 mg, 200 mg and 400 mg capsules.

Actavis maintains that the FDA improperly awarded sole exclusivity on generic Celebrex® to Teva Pharmaceutical Industries Ltd., despite an earlier ruling from the U.S. Court of Appeals for the Federal Circuit that resulted in the triggering and subsequent expiration of Teva's sole exclusivity on the product.

Actavis is seeking a judgment from the U.S. District Court for the District of Columbia declaring that the FDA decision is arbitrary, capricious and contrary to law, as well as the entry of an injunction directing FDA to approve its ANDA for generic Celebrex® no later than the same date that the first ANDA for a generic version of Celebrex® is approved. Actavis is also asking the Court to issue an injunction granting a 180-day exclusivity period for generic Celebrex® to Actavis as a first filer of a substantially complete ANDA containing a Paragraph IV certification to U.S. Patent No. RE44,048.

For the 12 months ending December 31, 2013, Celebrex® had total U.S. sales of approximately $2.2 billion, according to IMS Health data.

About Actavis

Actavis plc (NYSE: ACT) is a global, integrated specialty pharmaceutical company focused on developing, manufacturing and distributing generic, brand and biosimilar products. Actavis has global headquarters in Dublin, Ireland and U.S. administrative headquarters in Parsippany, New Jersey, USA.

Actavis develops and manufactures generic, brand, branded generic, legacy brands and Over-the-Counter (OTC) pharmaceutical products and has commercial operations in approximately 60 countries. The Company's North American branded pharmaceuticals business is focused principally in the Women's Health, Urology, Gastroenterology and Dermatology therapeutic categories with a strong pipeline of products in various stages of development. Actavis also has a portfolio of five biosimilar products in development in Women's Health and Oncology. Actavis Global Operations has more than 30 manufacturing and distribution facilities around the world, and includes Anda, Inc., a U.S. pharmaceutical product distributor.

For press release and other company information, visit Actavis' Web site at http://www.actavis.com.

Forward-Looking Statement

Statements contained in this press release that refer to non-historical facts are forward-looking statements that reflect Actavis' current perspective of existing information as of the date of this release. It is important to note that Actavis' goals and expectations are not predictions of actual performance. Actual results may differ materially from Actavis' current expectations depending upon a number of factors, risks and uncertainties affecting Actavis' business. These factors include, among others, the inherent uncertainty of litigation, including the litigation against the FDA concerning Actavis' ANDA for its celecoxib product, and risks that Actavis will not prevail in such litigation; the difficulty of predicting the timing or outcome of product development efforts, including FDA and other regulatory agency approvals and actions, if any; the impact of competitive products and pricing; the timing and success of product launches; risks that resolution of patent infringement litigation through settlement could result in investigations or actions by private parties or government authorities or agencies; difficulties or delays in manufacturing; the availability and pricing of third party sourced products and materials; successful compliance with FDA and other governmental regulations applicable to Actavis' and its third party manufacturers' facilities, products and/or businesses; changes in the laws and regulations, including Medicare and Medicaid, affecting among other things, pricing and reimbursement of pharmaceutical products; and such other risks and uncertainties detailed in Actavis' periodic public filings with the Securities and Exchange Commission, including but not limited to Actavis plc's Annual Report on Form 10-K for the year ended December 31, 2013. Except as expressly required by law, Actavis disclaims any intent or obligation to update these forward-looking statements.

Celebrex® is a registered trademark of Pfizer, Inc.

CONTACTS:

Investors:
Lisa DeFrancesco
(862) 261-7152

Media:
Charlie Mayr
(862) 261-8030

David Belian
(862) 261-8141

Actavis plc logo

Photo - http://photos.prnewswire.com/prnh/20130124/NY47381LOGO

SOURCE Actavis plc



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