The Abbreviated New Animal Drug Application (ANADA) process is for the approval of generic copies of new animal drug products that have been previously approved and shown to be safe and effective. This process was established in 1988, when the Generic Animal Drug and Patent Term Restoration Act (GADPTRA) was signed into law, amending the Federal Food, Drug, and Cosmetic Act. The ANADA process is “abbreviated” because the drug sponsor doesn't have to conduct new safety and effectiveness studies with the generic animal drug.
A generic new animal drug must contain the same active ingredient, in the same concentration, dosage form, and route of administration as the new animal drug being copied (the reference listed new animal drug (RLNAD)) unless a suitability petition has been granted to allow for certain differences. Additionally, the labeling of a generic product must be the same as the RLNAD labeling apart from information specific to the generic new animal drug such as tradename, logo, sponsor name and address.
To gain approval of a proposed generic new animal drug, the ANADA must include identification of the RLNAD and information to satisfy the following technical sections:
- In August 2017, FDA officially deployed the eSubmitter Blood Level Bioequivalence Study Protocol QbR Template. This template has been designed to increase transparency and efficiency of the blood level bioequivalence study protocol review process as part of the generic animal drug approval process. If you have questions regarding the eSubmitter Blood Level Bioequivalence Study Protocol QbR Template or would like to obtain a written copy of the template, please contact CVM.DGAD.QBR@fda.hhs.gov.
- Patent Certification and Marketing Exclusivity
- Chemistry and Manufacturing Controls
- Environmental Impact
- Human Food Safety (only applicable when the drug is intended for use in a food-producing animal)
There are two pathways for the submission of technical sections to support approval of a generic new animal drug. An ANADA may be submitted as a complete application and reviewed. See 21 CFR 514.1 for more details. The ANADA must be submitted electronically through the eSubmitter portal where all components will be addressed in a question-based format. Once the various components are reviewed, the sponsor receives a letter indicating whether the application is complete or incomplete and, in the case of an incomplete application, deficiencies are described.
Alternatively, the technical sections may be submitted under the phased review process. In the phased review process, technical sections are reviewed under the established generic investigational new animal drug (JINAD) file by the appropriate review group within CVM and once each technical section is found complete, an administrative ANADA can be filed.
In 2008, the Animal Generic Drug User Fee Act (AGDUFA) established a user fee program. This program established defined performance goals and authorizes FDA to collect user fees for certain abbreviated applications for generic new animal drugs, generic new animal drug products, and from certain sponsors of abbreviated applications for generic new animal drugs and/or investigational submissions for generic new animal drugs. For information on current AGDUFA user fees please visit Animal Generic Drug User Fee Act (AGDUFA).
If you have questions regarding the ANADA process, please contact the Division of Generic Animal Drugs at CVMDGADMGT@fda.hhs.gov.