Abbreviated New Animal Drug Applications
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:
- 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 FDA’s Electronic Submissions Gateway (ESG) using CVM’s eSubmitter tool to generate the submission 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.
A U.S. agent is a person who resides or maintains a place of business within the U.S., and who serves as the responsible official for a foreign sponsor. A U.S. agent is required for submissions to a generic investigational new animal drug (JINAD) or an abbreviated new animal drug application (ANADA) file. Electronic (eSubmitter) submissions to these files must be made by the U.S. agent or their representative (a colleague to whom the U.S. agent delegates eSubmitter responsibility).
When the initial submission (A-0000) to establish a file is made by the U.S. agent, the U.S. agent should include a signed letter from the foreign sponsor stating that they are appointing [person or company] as their U.S. agent. The U.S. agent may be a specific person or company (for example, “John Smith” or “John Smith Consulting”). The letter appointing the U.S. agent should also contain contact information for the U.S. agent including their email address, telephone number, and mailing address. The U.S. agent for a foreign sponsor may be changed through a general correspondence (G) submission to all applicable files; the G submission should include a signed letter from the foreign sponsor as outlined above.
- FDA TRACK: AGDUFA Animal Generic Drug Applications and Supplements
- CVM/Office of New Animal Drug Evaluation (ONADE) Reviewer's Chapter
- Electronic Submissions
- Policy and Procedures Manual 1243.2020 - United States Agents
- Approved Animal Drug Products (Green Book)
- Compilation of FDA Guidance and Resources for in vitro Dissolution Testing of Immediate Release Solid Oral Dosage Forms