FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: DETERMINATION THAT ETHYOL (AMIFOSTINE) FOR INJECTION, 500 MILLIGRAMS/VIAL, WAS NOT WITHDRAWN FROM SALE FOR REASONS OF SAFETY OR EFFECTIVENESS

WASHINGTON, April 9 -- Food and Drug Administration has issued a notice called: Determination That ETHYOL (Amifostine) for Injection, 500 Milligrams/Vial, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness.

The notice was published in the Federal Register on April 9 by P. Ritu Nalubola, Associate Commissioner for Policy.

Summary: The Food and Drug Administration (FDA, the Agency, or we) has determined that ETHYOL (amifostine) for injection, 500 milligrams (mg)/vial, was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue ...