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Business · 12/03/2021Updated: 10/17/2026 · 1 min read

FDA Withdraws Approval of Five Bacitracin ANDAs

Summary

The FDA has withdrawn approval of five abbreviated new drug applications for Bacitracin for Injection from Akorn, Mylan, Pfizer, X-GEN, and Fresenius, following requests from the applicants to waive a hearing.

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

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