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Business · 15/05/2023Updated: 10/17/2026 · 1 min read

FDA Announces Final Decision on Withdrawal of MAKENA and Eight Abbreviated New Drug Applications

Summary

The FDA has made a final decision to withdraw approval of MAKENA and eight abbreviated new drug applications following a public hearing in October 2022, as announced by the Commissioner of Food and Drugs and the Chief Scientist.

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

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