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April 01, 2011


 FDA extends comment period on unapproved animal drugs

posted March 18, 2011

The Food and Drug Administration is extending until April 19 the deadline for submitting comments on strategies to address categories of animal drug products that are on the market without FDA approval or other legal marketing status.

The agency's Dec. 20, 2010, request for comments indicates that the unapproved animal drugs of concern include such products as injectable vitamins; various topical solutions, shampoos, and liniments; electrolyte and glucose solutions; antidotes; and a variety of anti-infective products.

Despite media reports, the AVMA believes that the FDA initiative on unapproved animal drugs does not pertain to compounded drugs, said Dr. Lynne A. White-Shim, an assistant director of the AVMA Scientific Activities Division.

Dr. White-Shim added at press time that the AVMA was drafting comments regarding the FDA initiative on unapproved animal drugs.

According to the request for comments, the FDA is looking for approaches to decrease the number of animal drug products that are on the market without FDA approval or other legal marketing status. The agency is exploring additional mechanisms for these products to achieve legal marketing status, rather than revising the process for approving new animal drugs.

Parties may view the request for comments and submit comments at by searching for FDA-2010-N-0528. Comments may be submitted by mail to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.