Submission of New Animal Drug Applications and Abbreviated New Animal Drug Applications

CVM approval for drug products is a complex and technically challenging process. Our toxicologists which specialize in animal products can answer questions such as whether certain antibiotics are safe in food-producing animals as well as the safety of pet food and animal feed products as well as the acceptability and safety of animal food/feed ingredients. We can help prepare submissions for FDA review and approval.

  • NADA (New Animal Drug Application): Similar to NDAs for human foods, NADA sponsors may petition the FDA for approval of a new pharmaceutical for sale and marketing in the U.S. through a New Drug Application using the data gathered during the animal studies.
  • ANADA (Abbreviated New Animal Drug Application or generic drug): Similar to ANDAs for human use, ANADAs are generic drug “abbreviated” applications because they are generally not required to submit preclinical and clinical data to establish safety and effectiveness. Instead, generic applicants must demonstrate bioequivalence.