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On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

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  1. CVM Offices

Office of Generic Animal Drugs

On September 26, 2024, the FDA’s Center for Veterinary Medicine announced the reorganization of the Office of New Animal Drug Evaluation into two separate offices that will handle pre-market evaluation of originator animal products and generic drugs. The reorganization implementation is effective as of October 20, 2024.

The major responsibility of the Office of Generic Animal Drugs (OGAD) is to review information submitted by drug sponsors who want approval to manufacture and market generic copies of new animal drug products that have been previously approved and shown to be safe and effective. Generic animal drugs cannot be legally marketed unless they have been reviewed and approved by FDA.

Generic animal drugs must contain the same active ingredients, in the same concentration, dosage form, and route of administration, as the new animal drug product they are copying (also called the reference-listed new animal drug, RLNAD, or originator), unless a suitability petition has been granted to allow for certain differences.

The Office of New Animal Product Evaluation evaluates applications for originator new animal drug products and determines whether to approve them for marketing. This process establishes a product’s safety and effectiveness. OGAD relies on these findings in the evaluation of generic animal drugs and does not require additional safety or effectiveness studies to support approval. However, applications to market generic animal drugs must establish, among other things, that they are bioequivalent to the RLNAD and that they are manufactured according to quality standards and Good Manufacturing Practice regulations. The labeling of a generic animal drug must be the same as the RLNAD’s labeling except for information specific to the generic animal drug, such as tradename, logo, sponsor name and address.

FDA approves a generic animal drug for marketing when the regulatory standards for approval are met. Once in the marketplace, FDA’s Office of Surveillance and Compliance continues to monitor the generic animal drug to ensure that these standards are sustained. 

OGAD's review process includes:

  • Meeting with sponsors to discuss development plans and reaching agreement on the requirements for approval.
  • Reviewing submitted study protocols to ensure the studies will provide the necessary information to support the approval.
  • Reviewing suitability petitions to determine if a generic animal drug can differ in certain specific ways from the RNLAD.
  • Ensuring the generic animal drug is bioequivalent to the RLNAD.
  • Ensuring edible products (such as meat, milk or eggs) made from food-producing animals treated with generic animal drug are safe for humans to eat.
  • Evaluating the impact of generic animal drugs on the environment.
  • Evaluating manufacturing methods and procedures for generic animal drugs.
  • Ensuring any relevant patents or marketing exclusivities are either expired or appropriately addressed by the generic sponsor prior to approval.
  • Reviewing the drug labeling to ensure it is the same as the RLNAD labeling, except where permitted.
  • Preparing a Freedom of Information (FOI) summary of the information the agency relied upon to support approval.
  • Coordinating the development and implementation of regulations and policies pertaining to the development of generic animal drugs.

Additional Resources

 



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