Collaboration Details

Title of Collaborative Activity:

FDA Antimicrobial Drugs Advisory Committee (FDA AMDAC)

Description of Collaborative Activity:

Discuss new drug application (NDA) 215596, for maribavir oral tablets, submitted by Takeda Pharmaceuticals USA, Inc., for the treatment of adults with post-transplant cytomegalovirus infection and/or disease, including infections resistant and/or refractory to ganciclovir, valganciclovir, cidofovir, or foscarnet.

Type of Collaborative Activity:

Committee, Advisory Group, or Work Group

Year the Collaborative Activity Originated:

2021

NIH Participating Institutes/Centers/Office of the Director:

NIAID

HHS Agency Collaborators on this Activity:

FDA