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ARTICLE | Company News

FDA approves Genentech flu therapy

October 24, 2018 5:45 PM UTC

FDA approved Xofluza baloxavir marboxil from Genentech Inc. to treat acute uncomplicated influenza in patients ages 12 and older who have been symptomatic for no more than 48 hours. The approval comes two months ahead of Xofluza's Dec. 24 PDUFA date; the NDA was under Priority Review.

FDA Commissioner Scott Gottlieb said the drug is the "first new antiviral flu treatment with a novel mechanism of action approved by the FDA in nearly 20 years."...