US FDA accepts New Drug Application (NDA) for new formulation of baloxavir for the treatment of influenza in children
The NDA is for granules for oral suspension (2mg/mL). The application also seeks approval of baloxavir for the treatment of acute uncomplicated influenza in children aged 1 to <12 years, and for post-exposure prophylaxis in people aged 1 year (tablet and granules).
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Biospace Inc.
SPS commentary:
In the US, baloxavir is currently available in tablet form, licensed for the treatment of acute uncomplicated influenza in patients 12 years of age and older who have been symptomatic for no more than 48 hours. A centralised marketing authorisation application was submitted to the EU in December 2019; final approval is awaited.