FDA Clears ANTIZOL Injection for Sale, Citing Lack of Safety or Effectiveness Concerns

Summary

The US Food and Drug Administration (FDA) has made a determination that ANTIZOL (fomepizole) Injection, a 1.5g/1.5mL formulation, was not withdrawn from sale due to concerns over its safety or effectiveness, allowing the FDA to continue approving abbreviated new drug applications (ANDAs) for this product as long as they meet relevant regulatory requirements.