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Genentech: FDA To Review NDA For Xofluza - Quick Facts

Genentech, a member of the Roche Group (RHHBY), said FDA has accepted a New Drug Application as well as two supplemental New Drug Applications for Xofluza. Xofluza is FDA-approved to treat influenza in people 12 years of age and older. The New Drug Application for Xofluza is for the treatment of Influenza in Children. The FDA is expected to make a decision on these approvals by November 23, 2020.

The NDA is for a new formulation of Xofluza, potentially offering a more convenient option for children and those who have difficulty swallowing. The application also seeks approval of Xofluza for the treatment of acute uncomplicated influenza in otherwise healthy children aged one to less than 12 years of age who have been symptomatic for no more than 48 hours.

The FDA also accepted an sNDA for post-exposure prophylaxis of influenza in people one year of age and older for both the oral suspension and currently-available tablet formulation.

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