Here is a look at infectious disease-related FDA news from the week of March 22, 2020.
Here is a look at infectious disease-related US Food and Drug Administration (FDA) news from the week of March 22, 2020.
FDA Accepts New Drug Application for Baloxavir Marboxil for Treatment of Influenza In Children
Genentech, a member of the Roche Group, announced that the FDA has accepted a New Drug Application (NDA) as well as 2 supplemental New Drug Applications (sNDA) for baloxavir marboxil.
The application seeks approval of an additional formulation of baloxavir marboxil for oral suspension for people one year of age and older with influenza.
The FDA also accepted a supplemental New Drug Application for the use of baloxavir marboxil
for post-exposure prophylaxis, potentially offering baloxavir marboxil as a preventive treatment for influenza after exposure to an infected individual.
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