US Animal Drugs


Posted By: Selerant RSA

New Animal Drugs applications

Ceftiofur Sodium; Gentamicin; Xylazine.

April 15, 2014; The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during March 2014. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of sponsorship for an ANADA. This rule is final, Technical Amendment. Its effective date is April 15, 2014.

More information: New Animal Drug Application (21 CFR 522)

Amprolium; Bambermycins; Ceftiofur; Deslorelin; Florfenicol; Florfenicol and Flunixin; Paclitaxel; Phenylbutazone; Pimobendan; Salinomycin; Tilmicosin; Tiludronate; Change of Sponsor.

April 1, 2014; The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during January and February 2014. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect previous approval of revised food safety warnings. This is being done to improve the accuracy of the regulations. The animal drug regulations are also being amended to reflect a change of sponsorship of an NADA and a change to a sponsor's address. This rule is final. Its effective date is April 1, 2014.

More information: New Animal Drug Application (21 CFR 510, 516, 520, 522, 526&558)

 

Withdrawal of Approval of New Animal Drug Applications

Bambermycins; Hygromycin B; Lincomycin; Pyrantel; Tylosin; Tylosin and Sulfamethazine; Virginiamycin.

April 10, 2014; The Food and Drug Administration (FDA) is withdrawing approval of 19 new animal drug applications (NADAs) for certain Type A medicated articles and Type B medicated feeds. This action is being taken at the sponsors' request because these products are no longer manufactured or marketed. This rule is final. Its effective date is April 21, 2014.

More information: New Animal Drug Application (21 CFR 510&558)

Chlortetracycline; Sulfathiazole; Penicillin.

March 20, 2014; The Food and Drug Administration (FDA) is withdrawing approval of a new animal drug application (NADA) and two abbreviated new animal drug applications (ANADAs) for three-way, fixed-ratio combination drug Type A medicated articles containing chlortetracycline, sulfathiazole, and penicillin. This action is being taken at the sponsor's request because these products are no longer manufactured or marketed. This rule is final. Its effective date is March 31, 2014.

More information: New Animal Drug Applications (21 CFR 558)