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Fly News Breaks for January 18, 2017
JAZZ
Jan 18, 2017 | 07:48 EDT
Wells Fargo analyst David Maris noted that the FDA granted a generic Xyrem approval last night, but also that the agency also granted Jazz's citizen's petition related to the drug, which he sees as a "major win." The citizen's petition, in which Jazz asserted that drug-drug interaction safety information included on branded Xyrem's label should not be omitted from the label of a generic version of Xyrem, is a big win as Maris believes a generic is unlikely to launch prior to the expiration or invalidation of the patents which cover the DII safety information, he tells investors. The grant of the petition increases the chances of a settlement and adds to the protection of Jazz's Xyrem franchise, added Maris, who keeps an Outperform rating on the shares.
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