FDA-TRACK: Center for Veterinary Medicine - Pre-market Animal Drug Review
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FDA's Center for Veterinary Medicine (CVM) regulates animal drugs, animal devices and animal food under the Federal Food, Drug and Cosmetic Act. CVM protects and promotes the health of humans and animals by ensuring the safety of the American food supply, the safety of animal food and devices, and the safety and effectiveness of animal drugs.
The Center for Veterinary Medicine (CVM) evaluates and approves new animal drugs for all species including food-producing animals, such as poultry, cattle, and swine; exotic animals, including zoo animals; wildlife; and companion animals, such as dogs, cats, and horses. The approval of new animal drugs is critical to promoting the well-being of animals and the safety of the food supply.
New Animal Drug Applications (NADAs) are evaluated for safety (both for the target animal's safety and, in the case of drugs intended for use in food-producing animals, human food safety), effectiveness, manufacturing quality, and appropriate labeling. In addition, FDA reviews the environmental impacts of approving a new animal drug under the National Environmental Policy Act.
Abbreviated New Animal Drug Applications (ANADAs) are submitted for generic copies of brand name drugs. Generic animal drugs are the same as brand name drugs in concentration, dosage form, and route of administration (unless suitability petition has been granted). Generic animal drugs must have the same labeling as their brand name counterparts, apart from information specific to the generic drug, such as the tradename, and sponsor name and address. Generic animal drugs are evaluated for bioequivalence to ensure that the generic drugs offer the same therapeutic value as their brand name counterparts. In addition, ANADAs are evaluated for manufacturing quality and, in the case of food-producing animals, human food safety. FDA reviews the environmental impacts of generic drug approvals under the National Environmental Policy Act.
As used in this FDA-TRACK webpage, these terms are defined as follows:
- Pioneer Original Approval: the initial NADA filed under section 512(b)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for a particular new animal drug product.
- Pioneer Original Approval - New Chemical Entity: an active ingredient that has never before been approved in any FDA application for an animal drug.
- Pioneer Original Approval - New Biological Product: a biologically-derived product, such as a cell or gene therapy or intentional genomic alteration in an animal, that has never been approved in any FDA application for animals.
- Pioneer Supplement: a supplement to an approved NADA for which safety or effectiveness data are required.
- Conditional Approval - MUMS: an application filed and conditionally approved under section 571(a)(1)(A)(i) of the FD&C Act.
- Conditional Approval - Expanded: an application filed and conditionally approved under section 571(a)(1)(A)(ii) of the FD&C Act.
- Generic Original Approval: the initial ANADA filed under section 512(b)(2) of the FD&C Act for a generic copy of a pioneer product approved under section 512(b)(1).
- Emergency Use Authorization: a product authorized to address an emergency under section 564 of the FD&C Act.
For additional information, visit CVM's Recent Animal Drug Approvals web page.
Download FDA-TRACK CVM Pre-market Animal Drug Review Dataset
Note: The data provided on this website are produced on an ongoing basis for performance management purposes and are subject to change due to updates of preliminary estimates, corrections, or other reasons.