Zdrowie i gospodarka · 07/06/2007

Determination That CEFOTAN (Cefotetan Disodium For Injection), Equivalent 1 Gram Base/Vial and 2 Grams Base/Vial, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

The Food and Drug Administration (FDA) has determined that CEFOTAN (cefotetan disodium for injection), equivalent 1 gram (g) base/ vial and 2 g base/vial, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for cefotetan disodium for injection, equivalent 1 g base/vial and 2 g base/vial, if all other legal and regulatory requirements are met.