ETHYOL Cancer Drug Stays Eligible for Generic Approvals
Published Date: 4/9/2025
Notice
Summary
The FDA checked and confirmed that ETHYOL (amifostine) 500 mg injection wasn’t taken off the market because of safety or effectiveness problems. This means drug companies can keep making and selling generic versions of ETHYOL as long as they follow the rules. Patients and healthcare providers can keep counting on this medicine without any interruptions or extra costs.
Analyzed Economic Effects
2 provisions identified: 2 benefits, 0 costs, 0 mixed.
Generic approvals may continue
The FDA determined that ETHYOL (amifostine) for injection, 500 milligrams/vial, was not withdrawn from sale for reasons of safety or effectiveness. Because of that finding, the FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this product, and the Agency will allow continued approval of ANDAs that refer to the product so long as they meet legal and regulatory requirements.
Patients face no interruption or extra cost
Patients and healthcare providers can continue to rely on ETHYOL (amifostine) for injection, 500 milligrams/vial, because the FDA found it was not withdrawn for safety or effectiveness. The notice says this means there should be no interruptions in access to the medicine or extra costs tied to its withdrawal from the market.
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