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Actavis Sues FDA Regarding Delay Of Generic CelebrexA® Approval

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.

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