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Imprese · 22/12/20211 min di lettura
Determination That ANTIZOL (Fomepizole) Injection, 1.5 Grams/1.5 Milliliters, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
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Riepilogo
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(FDA or Agency) has determined that ANTIZOL (fomepizole) Injection, 1.5 grams (g)/1.5 milliliters (mL), was not withdrawn from sale for reasons of safety or effectiveness.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.
Lingua originale della fonte: Federal Register — Food and Drug AdministrationApri il comunicato originale →