The committee will 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.
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Earlier Event: September 30
Vaccines and Related Biological Products Advisory Committee
Later Event: October 14
Vaccines and Related Biological Products Advisory Committee