Actavis sues U.S. drug regulator over generic Celebrex
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[April 29, 2014]
said on Monday it has sued the U.S. Food and Drug Administration,
challenging its decision to award exclusive rights to Teva
Pharmaceutical Industries Ltd to sell a generic version of Pfizer
Inc's blockbuster painkiller Celebrex.
A similar lawsuit was announced Friday by Mylan Inc
over generic drug marketing exclusivity for Celebrex.
Actavis alleges that FDA improperly awarded sole exclusivity to Teva
despite an earlier ruling from the U.S. Court of Appeals for the
Federal Circuit that resulted in the expiration of that entitlement.
Teva, the world's largest generic drugmaker, earlier this month
signed a deal that would allow it to launch a generic version of
Celebrex in December. Celebrex's basic chemical patent is set to
expire this May.
Deals between patent holders and generic drugmakers have come under
increased regulatory scrutiny because of their potential to delay
the launch of cheaper medicines.
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Celebrex, which is used to treat arthritis pain and inflammation,
generated about $2.92 billion in sales in 2013, according to
Pfizer's annual regulatory filing.
(Reporting by Susan Kelly in Chicago;
editing by Bernard Orr and
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