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Business · 17/02/2023Updated: 10/17/2026 · 1 min read

FDA Withdraws Approval of Miles Laboratories Inc.'s Alcohol and Dextrose Injection

Summary

The FDA is withdrawing approval of Miles Laboratories Inc.'s abbreviated new drug application for Alcohol and Dextrose Injection due to repeated failure to file required annual reports and concerns over the drug's safety under its approved conditions.

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

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