Business · 28/03/2000Updated: 10/17/2026 · 1 min read
FDA Proposes Withdrawal of 158 ANDA Approvals Amid Repeated Delays in Annual Reports
Summary
The US Food and Drug Administration (FDA) is seeking public input on a proposal to revoke the approval of 158 abbreviated new drug applications (ANDAs) due to repeated failures to submit required annual reports.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →