FDA Approves Ceftiofur Sodium Powder

The Food and Drug Administration amended the animal drug regulations to reflect approval of an original abbreviated new animal drug application (ANADA) filed by Cephazone Pharma LLC. The ANADA provides for the use of ceftiofur sodium powder for injection as a solution in dogs, horses, cattle, swine, day old chickens, turkey poults, sheep and goats as therapy for various bacterial infections.

The rule became effective July 15.

Cephazone Pharma LLC's ceftiofur sodium sterile powder is approved as a generic copy of

NAXCEL (ceftiofur sodium) sterile powder for injection, sponsored by Pharmacia & Upjohn Co., a Division of Pfizer Inc., under NADA 140-338.

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