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FDA Finds ETHYOL Was Not Withdrawn for Safety or Effectiveness Reasons
April 09, 2025
WASHINGTON, April 9 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has confirmed that ETHYOL (amifostine) for injection, 500 milligrams per vial, was not removed from the market due to concerns about safety or effectiveness.

This conclusion, published in the Federal Register on April 9, 2025, ensures that the agency will continue to approve generic versions of the drug as long as they meet legal and regulatory requirements under the abbrevia . . .

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