XOFLUZA® (BALOXAVIR MARBOXIL)


Associated tags: Biotechnology, FDA, Sinusitis, RO, Post-exposure prophylaxis, Antacid, Headache, Shanda, Korea Disease Control and Prevention Agency, Tell, ROG, New Drug Application, Pediatrics, Food, Breast milk, Bronchitis, Vaccine, Fine chemical, Pharmaceutical industry, Toy

Genentech Announces FDA Approval of Xofluza to Treat Influenza in Children Aged Five and Older

Retrieved on: 
Thursday, August 11, 2022

Additionally, the FDA approved Xofluza for the prevention (post-exposure prophylaxis) of influenza in children aged five to less than 12 years of age following contact with someone with influenza.

Key Points: 
  • Additionally, the FDA approved Xofluza for the prevention (post-exposure prophylaxis) of influenza in children aged five to less than 12 years of age following contact with someone with influenza.
  • However, in the U.S. 2018-2019 influenza season, there were more than 6 million illnesses, thousands of hospitalizations and more than 100 deaths for children aged five to 17 caused by influenza.
  • Todays FDA approval provides children with a single-dose antiviral option, Xofluza, to treat influenza."
  • BLOCKSTONE evaluated Xofluza compared with placebo as a preventive treatment for household members (adults and children) who were living with someone with influenza.

Genentech Announces FDA Approval of Xofluza for the Prevention of Influenza Following Contact With an Infected Person

Retrieved on: 
Monday, November 23, 2020

BLOCKSTONE evaluated Xofluza compared with placebo as a preventive treatment for household members (adults and children) who were living with someone with influenza.

Key Points: 
  • BLOCKSTONE evaluated Xofluza compared with placebo as a preventive treatment for household members (adults and children) who were living with someone with influenza.
  • Xofluza showed a statistically significant prophylactic effect on influenza after a single oral dose in people exposed to an infected household contact.
  • Xofluza is also approved for post-exposure prophylaxis of influenza in people 12 years of age and older following contact with an individual who has influenza.
  • Prevent the flu in people 12 years of age and older following contact with a person who has the flu.

FDA Accepts Genentech’s New Drug Application for Xofluza for the Treatment of Influenza in Children

Retrieved on: 
Friday, March 27, 2020

Todays milestone brings us closer to providing single-dose Xofluza to children with influenza, said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development.

Key Points: 
  • Todays milestone brings us closer to providing single-dose Xofluza to children with influenza, said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development.
  • We also look forward to working with the FDA to incorporate Xofluza as a preventive treatment following exposure to influenza.
  • Xofluza tablets are currently approved in many countries around the world for the treatment of influenza types A and B.
  • BLOCKSTONE evaluated Xofluza compared with placebo as a preventive treatment for household members (adults and children) who were living with someone with influenza.