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Petition to the FDA to Amend the List of Drug Products That Were Withdrawn or Removed From the Market Because They Were Deemed Unsafe or Ineffective to Include Hydroxyprogesterone Caproate for Prevention of Preterm Birth

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Public Citizen petitioned the Food and Drug Administration (FDA) to promptly initiate the regulatory process to amend the list of drug products that were withdrawn or removed from the market for reasons of safety or effectiveness and that therefore may not be compounded to include hydroxyprogesterone caproate injection for prevention of preterm birth.

April 27, 2023, FDA acknowledgment letter.

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