Antibiotic Drugs; Cefotetan and Cefotetan Sodium Injection

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The Food and Drug Administration (FDA) is amending the antibiotic drug regulations to provide for the inclusion of accepted standards for a new bulk form of cefotetan, cefotetan, and for its use in a new dosage form of cefotetan sodium, cefotetan sodium injection. The manufacturer has supplied sufficient data and information to establish its safety and efficacy.