Novartis Sues FDA For OK'ing Generic Herpes Drug

Law360, New York (September 23, 2010, 6:03 PM EDT) -- Novartis Pharmaceuticals Corp. has accused the U.S. Food and Drug Administration of improperly granting Watson Laboratories Inc.’s abbreviated new drug application for a generic version of herpes treatment drug Famvir.

In its complaint against the FDA filed Wednesday in the U.S. District Court for the District of Columbia, Novartis said it holds sole marketing rights for Famvir until next year — an exclusivity that the company argues has been threatened by the FDA’s Sept. 14 approval of the ANDA in alleged violation of the Federal Food,...
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