Business · 09/04/2021Updated: 10/17/2026 · 1 min read
FDA Withdraws Approval of Five Abbreviated New Drug Applications from Multiple Holders
Summary
The US Food and Drug Administration (FDA) has withdrawn the approval of five abbreviated new drug applications (ANDAs) from various holders due to repeated failure to submit required annual reports and implement approved risk evaluation and mitigation strategies (REMS).
Original source language: Federal Register — Food and Drug AdministrationOpen original release →