The Food and Drug Administration (FDA) announced that ETHYOL (amifostine) for injection, 500 mg/vial, was not removed from the market due to safety or effectiveness issues. This ruling implies that the FDA will not take action to revoke approvals for generic versions of this drug and can continue approving such versions if they comply with legal standards. The determination follows a petition and a review of available data, with no evidence found suggesting safety problems. As such, ETHYOL will stay on the "Discontinued Drug Product List" for reasons unrelated to safety or effectiveness.
Simple Explanation
The FDA decided that a medicine called ETHYOL, which is used to protect the body during cancer treatment, was not taken off the shelves because it is unsafe or doesn't work. This means other companies can still make and sell generic versions of it.