Esta tradução está a ser preparada. Entretanto, mostramos temporariamente a versão original em inglês.
Negócios · 13/02/20191 min de leitura
Takeda Pharmaceuticals U.S.A., Inc.; Withdrawal of Approval of a New Drug Application for OMONTYS (peginesatide) Injection
Tradução automática local · Idioma original da fonte
Resumo
The Food and Drug Administration (FDA) is withdrawing approval of new drug application (NDA) 202799 for OMONTYS (peginesatide) Injection, held by Takeda Pharmaceuticals U.S.A., Inc. (Takeda USA). Takeda Development Center America, Inc., on behalf of Takeda USA, requested withdrawal of approval of this application under relevant FDA regulations and, in so doing, has waived its opportunity for a hearing.
Idioma original da fonte: Federal Register — Food and Drug AdministrationAbrir o comunicado original →