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Entreprise · 22/12/20211 min de lecture
Determination That ANTIZOL (Fomepizole) Injection, 1.5 Grams/1.5 Milliliters, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
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Résumé
The Food and Drug Administration (FDA or Agency) has determined that ANTIZOL (fomepizole) Injection, 1.5 grams (g)/1.5 milliliters (mL), was not withdrawn from sale for reasons of safety or effectiveness.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 the ANDAs meet relevant legal and regulatory requirements.
Langue originale de la source: Federal Register — Food and Drug AdministrationOuvrir le communiqué original →