US Animal Drugs

Posted By: Selerant RSA

FDA confirms the effective date of Confidentiality of Data and Information in a New Animal Drug Application File.

July 1, 2014; The Food and Drug Administration (FDA) is confirming the effective date of July 30, 2014, for the final rule that appeared in the Federal Register of March 17, 2014. The direct final rule amends the regulation regarding the confidentiality of data and information in and about new animal drug application files to change when certain approval-related information will be disclosed by the Agency. This change ensures that the Agency is able to update its list of approved new animal drug products within the statutory timeframe. It also permits more timely public disclosure of approval-related information, increasing the transparency of FDA decision making in the approval of new animal drugs.

More Information: Confidentiality of Data and Information in a New Animal Drug Application File

New Animal Drugs applications: Afoxalaner; Ceftiofur Crystalline Free Acid; Chloramine-T; Clodronate; Enrofloxacin; Eprinomectin; Fluralaner; Ivermectin and Praziquantel; Niclosamide; Ractopamine; Tylosin; Change of Sponsor's Address.

July 2, 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 April and May 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 The animal drug regulations are also being amended to remove an obsolete entry for a drug for which approval was withdrawn in 1996.

More information: New Animal Drug Application (21 CFR 510, 520, 522,  529, 556&558)

Withdrawal of Approval of Part of a New Animal Drug Application: Procaine Penicillin

July 2, 2014; The Food and Drug Administration (FDA) is withdrawing approval of those parts of a new animal drug application (NADA) for a three-way, fixed-ratio, combination drug Type A medicated article that pertain to use of the procaine penicillin component for growth promotion indications in swine. This action is being taken at the sponsor's request because the three-way Type A medicated article is no longer manufactured.

More information: Notification Of Withdrawal (21 CFR 558)