Business · 24/04/2026Updated: 10/16/2026 · 1 min read

Egis Pharmaceuticals Limited, et al.; Withdrawal of Approval of Three Abbreviated New Drug Applications

Summary

The FDA is withdrawing approval of three ANDAs due to repeated failure to file required annual reports by the ANDA holders.

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

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