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Business · 19/07/2013Updated: 10/17/2026 · 1 min read

FDA Withdraws Approval of 52 New Drug Applications and 77 Abbreviated New Drug Applications

Summary

The US Food and Drug Administration (FDA) has withdrawn the approval of 52 new drug applications (NDAs) and 77 abbreviated new drug applications (ANDAs) from multiple pharmaceutical companies, following written notifications from the applicants that the drug products are no longer commercially available.

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

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