Business · 13/02/2019Updated: 10/17/2026 · 1 min read

Takeda Pharmaceuticals U.S.A., Inc. Withdraws Approval of OMONTYS Injection

Summary

The FDA is withdrawing approval of Takeda USA's new drug application for OMONTYS (peginesatide) Injection, following a request from Takeda Development Center America, Inc. on behalf of Takeda USA, to waive a hearing under FDA regulations.

Original source language: Federal Register — Food and Drug AdministrationOpen original release →

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