Business · 22/10/2021Updated: 10/17/2026 · 1 min read
Fresenius USA, Inc., et al.; Withdrawal of Approval of 216 Abbreviated New Drug Applications
Summary
The US Food and Drug Administration (FDA) is withdrawing approval of 216 abbreviated new drug applications (ANDAs) from multiple holders due to repeated failure to submit required annual reports, a requirement for maintaining approval.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →