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A Freedom of Information (FOI) Summary describes the safety and effectiveness information submitted by the drug sponsor to FDA to support the approval of a New Animal Drug Application (NADA) or Abbreviated New Animal Drug Application (ANADA). Under federal law,¹ FDA must release this information after the agency approves the application.

The FOI Summary provides the public with a summary of the information that FDA used to determine that the NADA or ANADA met the requirements for approval. Studies that the drug sponsor submitted to support the safety and effectiveness of the drug in the target animal species are summarized in the FOI Summary. For a drug for a food-producing species, the FOI Summary also includes summaries of human food safety studies that the sponsor submitted to demonstrate that food products made from treated animals are safe for people to eat.

Location of FOI Summaries

FOI Summaries are arranged by application number in Animal Drugs @ FDA.

The FOI Summary includes:

• General information about the approved new animal drug
• The drug’s indications for use, dosage form, and route of administration
• An explanation of the dosage regimen
• The agency's conclusions

If the FOI Summary is not electronically available

To obtain a copy of an FOI Summary that is not electronically available, please submit a written Freedom of Information Act (FOIA) request. Visit the "How to Make a FOIA Request" webpage for more information. FDA cannot accept FOIA requests via e-mail.

Environmental Assessments and Findings of No Significant Impact, where applicable, are listed by the established or chemical name of the drug’s active ingredient in Animal Drugs @ FDA.

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¹Title 21 of the Code of Federal Regulations, Part 514.11(e)