💊FDA Decision on ETHYOL
Determination That ETHYOL (Amifostine) for Injection, 500 Milligrams/Vial, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
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(FDA, the Agency, or we) has determined that ETHYOL (amifostine) for injection, 500 milligrams (mg)/ vial, was not withdrawn from sale for reasons of safety or effectiveness.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 to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$$ - High
The FDA's determination prevents the withdrawal of ETHYOL (amifostine) for safety or effectiveness reasons, allowing for continued approval of ANDAs, which benefits generic drug manufacturers and maintains market competition. This influences pricing strategies and product availability for businesses in the pharmaceutical sector.