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U.S. Department of Health and Human Services

Animal & Veterinary

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Letters to Sponsors of Affected Products

Guidance for Industry #213, "New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209" (GFI #213) lays out a road map for animal pharmaceutical companies to voluntarily revise the FDA-approved use conditions on the labels of affected products to remove production indications. The plan also calls for changing the current over-the-counter (OTC) status to bring the remaining appropriate therapeutic uses under veterinary oversight. Once manufacturers voluntarily make these changes, these medically important antimicrobial drugs can no longer be used for production purposes, and their use to treat, control, or prevent disease in animals will require veterinary oversight.

On December 12, 2013, FDA mailed letters to sponsors of applications initially identified as being affected by GFI #213. Applications were considered either as Pioneer, Generic, or Combination, which are described as follows:

Pioneer – A pioneer or original new animal drug application (NADA).

Generic - An abbreviated (generic) new animal drug application (ANADA) that references a single ingredient NADA application.

Combination – A combination new animal drug application (NADA or ANADA) that references several single ingredient NADA applications.

FDA asked the sponsors of pioneer or original new animal drug applications (NADA) the subject of GFI #213 to inform the Agency within three (3) months from the date of publication of this final guidance of their intentions to make these voluntary changes.

Revisions to the approved conditions of use in NADAs for pioneer products will affect the conditions of use in generic or combination applications that reference these pioneer applications. When pioneer applications are revised, FDA will work expeditiously with sponsors to align the generic and combination applications with the revised conditions of use in the pioneer (i.e., reference) applications.