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FDA Flouting Court On Orphan Drug Exclusivity, Suit Says

Law360, New York (April 28, 2016, 7:57 PM EDT) -- The U.S. Food and Drug Administration is flouting a recent court ruling and federal law by refusing to grant orphan drug exclusivity for chemotherapy infusion Bendeka, according to a complaint filed Wednesday in D.C. federal court.

The suit filed by Bendeka developer Eagle Pharmaceuticals Inc. concerns a recently approved bendamustine drug that is promoted in the U.S. by Teva Pharmaceutical Industries Ltd. and intended to replace another bendamustine drug, Treanda, that is promoted by Teva and suddenly facing generic competition.

According to Eagle, the FDA is denying seven-year exclusivity that orphan drugs typically get on the grounds that Bendeka shares the...

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Attached Documents



Case Information

Case Title

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Case Number

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District Of Columbia

Nature of Suit

Other Statutory Actions


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Date Filed

April 27, 2016

Law Firms


Government Agencies